Medical devices & diagnostics · Fertility hormone testing
Inito
A smartphone connected urine test that reports four reproductive hormones as numbers instead of lines. Sold in India since 2018 and the United States since 2021, under an FDA exemption rather than an FDA clearance.
Fifteen seconds, then ten minutes
Dip the strip in urine for fifteen seconds. Cap it. Slide it into a small reader. Go do something else.
About ten minutes later the phone shows four numbers: estrogen, luteinising hormone, follicle stimulating hormone, and pregnanediol glucuronide, the urine metabolite of progesterone. Not a faint line to squint at. Values, plotted day over day.
That is the whole proposition. A drugstore ovulation kit reads one hormone and answers yes or no. Inito reads four and answers with a chart. The starter kit sells for $119 on the company site, cut from $169, with fifteen refill strips at $49.
The gap it is aimed at
Luteinising hormone surges about a day before an egg is released, which is why nearly every home ovulation test looks for it. Estrogen rises earlier, widening the window a test can flag. Neither shows whether an egg was released. Progesterone does, and its metabolite PdG rises only afterwards. Inito’s own paper in Scientific Reports puts about 26 to 37 percent of natural cycles as anovulatory.
Others crowd the space. MFB Fertility sells Proov, a visually read PdG strip. Mira sells a quantitative reader. Clearblue has sold LH and estrogen monitors for years. Natural Cycles sits in a different regulatory world, granted Class II status in 2018 as a contraceptive app on data from 15,570 women. Prediction, confirmation and contraception are three claims with three evidence burdens. Inito makes the first two.
Two Siemens engineers and a Sunday habit
Aayush Rai studied at IIT Roorkee. Varun AV, who publishes as Varun Akur Venkatesan, studied at IIT Madras. They met as research engineers at Siemens and, by TechCrunch’s account, worked the idea out on Sunday kayaking trips before quitting.
Most reporting dates the founding to 2015. The bank advising the 2025 round says 2014, and VCCircle records a pre seed cheque in late 2014. The product reached Indian shelves in 2018. Y Combinator lists the company in Winter 2019; Indian coverage from late 2019 called it Winter 2018.
The word that changed
On 2 November 2020 Indian wire copy went out under headlines saying a Bengaluru startup had won USFDA approval for a fertility monitor. Rai told the Indian Express the company had a class one approval. Moneycontrol called it an FDA licence.
The record is narrower. There is no 510(k), no premarket approval and no De Novo grant for Inito. What exists is an establishment registration and a device listing under product code NGE, luteinising hormone test, over the counter. The FDA classification database marks that code Class I and, under submission type, “510(K) Exempt”. Registration is an obligation for anyone shipping a device into the United States, not a verdict on it.
By 2023 the framing had tightened. TechCrunch reported it correctly: “The Inito Fertility Monitor is registered with the FDA as a Class I medical device that is exempt from FDA’s premarket notification submission requirements.” The current website makes no FDA claim at all.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA premarket record | No 510(k), no PMA and no De Novo. A search of the FDA 510(k) database by applicant returns no match as of Sep 23, 2026. | Public record |
| FDA registration and listing | Inito Health Tech Private Limited, Bangalore, registration 3038290392, listed May 7, 2025. Four Indian contract manufacturers have also listed Inito strips or readers since 2020: Centum Electronics, Ubio Biotechnology Systems, Immunoscience India and Biowick Healthcare. Every listing carries product code NGE and nothing else. | Public record |
| What NGE means | 21 CFR 862.1485, luteinising hormone test system, over the counter. Class 1. Submission type: “510(K) Exempt”. Not GMP exempt. | Public record |
| The 2020 approval coverage | The Times of India ran “Bengaluru startup Inito gets USFDA approval for fertility monitor” on Nov 2, 2020, from a company statement. The Economic Times carried the same copy. No FDA approval or clearance exists for this device. | Differs from the record |
| The mutual recognition claim | 360Dx, 2021: “The test system is a Class I device, Av said, and Inito markets it in the US under a mutual recognition agreement with the US Food and Drug Administration, which in essence recognizes the firm’s clinical trial data in India.” No such mechanism appears in the device record, and a 510(k) exempt device needs no recognised trial data to reach the market. | Differs from the record |
| Serum correlation study | Human Reproduction Open, Jan 2023. 73 data points from 20 participants. Urinary E3G, PdG and LH correlated with serum estradiol, progesterone and LH at R squared 0.96, 0.95 and 0.98. Registered as ISRCTN15534557. All four authors are co-founders or employees of the Indian research arm. | Public record |
| Assay validation study | Scientific Reports, Jun 2023. 100 women aged 21 to 45 with cycles of 21 to 42 days, plus a second group of 52. Coefficient of variation 5.05 percent for PdG, 4.95 for E3G, 5.57 for LH. A new ovulation confirmation criterion separated ovulatory from anovulatory cycles with “100% specificity” and an ROC area of 0.98. Same author group. | Public record |
| FSH evidence | Neither paper validates FSH. Both cover E3G, PdG and LH only. FSH was added later and no peer reviewed validation was found. | Not found |
| Adverse event reports | Four MAUDE reports, all coded malfunction: Dec 2022, Sep 2024 and two in Dec 2025. The 2022 report questions whether the device is FDA approved. One from Dec 2025 describes estrogen values the user believed were triple her normal. | Public record |
| The 99.12 percent figure | Quoted by the company since 2019 and repeated by Forbes India, Moneycontrol and the 2020 wire copy as an IIT Delhi finding. The report was not retrievable and is not peer reviewed. | Company-stated |
| Indian regulatory status | The company told the Indian Express in 2020 that it had sold in India since 2018 after Central Drugs Standard Control Organisation clearance. No licence number has been published. | Company-stated |
| Comparators that did clear | MFB Fertility obtained 510(k) K191462 for the Proov Test on Feb 27, 2020, under product code QKE, over the counter pregnanediol glucuronide immunoassay, now Class I exempt. Natural Cycles was granted De Novo Class II classification in 2018, for contraception. | Public record |
Read plainly: the measurement science is published and looks solid for three of the four hormones, but it came from the people who sell the device, on small cohorts of women with regular cycles and no diagnosed infertility. The US position is a registration, not a clearance, and for years the company and the press around it described it in stronger terms than the record supports.
What to watch
- Whether FSH or hCG validation is published, and whether it comes from authors outside the company.
- Whether the planned pregnancy, menopause and testosterone tests stay inside the Class I exempt boundary or need a 510(k).
- Whether a study appears in women with PCOS, irregular cycles or diagnosed infertility, the group the published cohorts excluded.
- The MAUDE queue. Four reports is small, but three landed after 2024.
In their words
“All of this in the same test strip is novel.”
Varun Av, chief technology officer, 360Dx, 2021 · Independent
“The coming years will see home diagnostics become an integral part of the medical ecosystem, and we’re proud to be among the leaders of this revolution.”
Aayush Rai, company statement carried by PTI, November 2020 · Company statement
“We are very proud of the fact that we have built something that is of a global standard and meets all the norms set out by the FDA. We are not just building for India, but building for the world from India.”
Aayush Rai to the Indian Express, November 2020 · Interview
“A home-use device can predict urinary hormone values which are well-correlated to serum concentrations of respective hormones and hence can be used as a proxy for serum measurements.”
Pattnaik, Das, Venkatesan and Rai, Human Reproduction Open, 2023 · Peer reviewed
“The study was designed to include women who have normal cycle lengths regularly; therefore, the values obtained were in the normal range. Certain infertility conditions may cause the values to be higher and correlation in such cases needs to be established.”
Same paper, stated limitation · Peer reviewed
“We predict how proteins fold in 3D, design synthetic antibodies using AI, and test millions of variants virtually before making a single one in the lab.”
Varun Venkatesan, co-founder and CTO, TechCrunch, December 2025 · Independent
“The real vision is bigger than adding new tests.”
Aayush Rai, co-founder and CEO, TechCrunch, December 2025 · Independent
Related companies
Sources
- Public recordFDA product classification, product code NGE, 21 CFR 862.1485
- Public recordFDA registration and listing records for Inito products
- Public recordFDA 510(k) database, no Inito record
- Public recordMAUDE adverse event reports, Inito devices
- Public record510(k) K191462, Proov Test, MFB Fertility
- Public recordPredicting serum hormone concentration through a home-use device
- Public recordValidation of urinary reproductive hormone measurements
- IndependentStartup Inito Sells At-Home Test Reader With Novel Fertility Targets
- IndependentInito raises $6M
- IndependentFertility startup Inito wants to use AI-designed antibodies
- IndependentMade-in-India Inito fertility monitor prepares for US launch
- IndependentBengaluru startup Inito gets USFDA approval for fertility monitor
- IndependentGiving DIY diagnostics a boost, the Inito way
- InterviewGetting expertise is a big problem in India: Inito’s Aayush Rai
- IndependentY Combinator-backed Inito brings fertility tests to homes
- IndependentInito bags $29 mn in Series B
- IndependentFDA clears Natural Cycles as a digital method of birth control
- CompanyInito homepage and product pages
- CompanyInito company page, Winter 2019 batch
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
