Medical devices & diagnostics · At-home testing
Scanwell Health
A Los Angeles company that turned a phone camera into a urinalysis reader and sold the first over-the-counter urine testing app in the United States. It became the software inside a Becton Dickinson COVID-19 test, and BD bought it in December 2021.
Thirty-two squares of printed color
The clever part was not the app. It was a piece of die cut card stock.
A phone camera does not see color the way a laboratory analyzer does. Kitchen light and daylight push the reading somewhere different. So the device the FDA cleared in September 2017 put the answer and the ruler in one photograph: a backing card carrying thirty two calibration color blocks, with a groove cut to hold the strip.
The user wets the two reagent pads, slots the strip in and photographs the card. The app compares the color that developed against the calibration blocks a few millimeters away, under the same light. The 510(k) summary says why they sit on the card rather than on the screen: so they are “subjected to the same conditions as the reagent pads for comparison.”
The chemistry was decades old; the predicate was a ten parameter dipstick cleared in 1997. What was new was that a person at home could produce a reading a clinician would accept.
Ten million visits a year
Urinary tract infections prompt about ten million doctor visits in the United States each year, according to Lemonaid Health, the telehealth company that became Scanwell’s distribution partner. Most are treated over the phone, from symptoms alone. Scanwell’s chief medical officer cited studies finding 30 to 50 percent of such cases treated inappropriately with antibiotics.
A strip costs pennies; the reading was the part that had always needed a person or a machine in a building. Three strips sold for $15, a Lemonaid consultation for $25, against roughly $150 for urgent care.
Born into the business
Stephen Chen did not arrive at urine chemistry by accident. His family built one of the larger urinalysis manufacturers in the country, his earliest memories of work being an assembly line and pregnancy tests.
After a Harvard MBA he joined Teco Diagnostics, the family firm in Anaheim, as an R&D manager and later a general manager. He left in 2013 to start Petnostics, a urine test for pets, was offered $300,000 for 20 percent of it on a television investment show, and did not take it. Petnostics revenue funded the human product instead. He says he began work on the smartphone device around 2011, when the FDA was still deciding how to regulate mobile medical apps. Y Combinator put in $120,000, and for a long stretch that was the whole outside capital.
The antibody test that never shipped
On March 19, 2020, Scanwell announced exclusive rights to license and distribute a SARS-CoV-2 rapid serology test made by Innovita of Hebei, China, for use at home: fifteen minutes, a finger stick, the app, a Lemonaid clinician, $70 at cost. Kits would ship six to eight weeks after an emergency use authorization, citing a five institution Chinese trial with 87.3 percent sensitivity and 100 percent specificity.
Three days earlier the FDA had widened its COVID-19 guidance to cover serology. Within days it clarified that the flexibility did not cover tests collected or run at home, and it alerted consumers that it “has not authorized any test that is available to purchase for testing yourself at home for COVID-19.” By July 2020 it was writing to other firms that “to date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing.”
Supply went wrong too: Innovita’s first shipment was held back when Chinese regulators told it to prioritize other orders. No authorization for the home antibody test appears in the record, and it never went on sale.
The phone becomes the analyzer
The other half of the idea did reach the market. In February 2021 BD announced a collaboration: a BD lateral flow antigen test read by the Scanwell app. On August 24, 2021 the FDA issued the emergency use authorization, to Becton, Dickinson and Co., for the BD Veritor At-Home COVID-19 Test. Shipments began October 26, two tests to a box at $39.99. No squinting at one line or two, ran the pitch, plus automatic reporting to public health agencies.
BD completed the purchase on December 21, 2021. Eighteen months later it asked the FDA to withdraw the authorization, and the agency revoked it on June 15, 2023.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K170118 | Cleared Sep 21, 2017 as the Scanostics UTI Check Application Test System, app plus URS-2L strips, for “the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection (UTI).” Over the counter, home use only. Predicate Clinistrip 10SGL, K970250. | Public record |
| Who holds it | The applicant of record is Teco Diagnostics of Anaheim, California, and the FDA 510(k) database returns no clearance under the name Scanwell Health. The summary adds that “The application’s core technology is based on four (4) patents held by Teco Diagnostics.” | Public record |
| The claim of a first | Company and BD releases state that “The company is the first and only to receive FDA 510(k) clearance for an over-the-counter diagnostic smartphone application.” The matching clearance is filed under Teco Diagnostics. A 2018 trade report has Scanwell, Inui Health and Healthy.io all clearing smartphone urinalysis devices, with only Scanwell’s sellable over the counter. | Differs from the record |
| Clinical evidence in the file | Lay user studies at three sites. No sensitivity or specificity figures appear, only that “Results indicate that the intended users were able to obtain comparable testing data when using the Scanostics UTI Check Application as a trained HCP using the Clinistrip (URS-10).” | Public record |
| Federal grants | NIH SBIR award R44ES032768 from NIEHS, An at-home test for chronic kidney disease: $801,217 in FY2020 and $801,864 in FY2021, $1,603,081 total, Sep 2020 to Aug 2023, PI Vivian Wang. No published results found. | Public record |
| COVID-19 antibody test | Announced March 2020 with a price, a supplier and a timeline. No emergency use authorization appears in the record; it never went on sale. | Not found |
| COVID-19 antigen test | “On August 24, 2021, FDA issued the Authorization to Becton, Dickinson and Co. for the BD Veritor At-Home COVID-19 Test.” The holder is BD; Scanwell supplied the app. Revoked Jun 15, 2023 “Because Becton, Dickinson and Co. notified FDA that it has discontinued the sale of BD Veritor At-Home COVID-19 Test.” | Public record |
| Where the entity sits now | Scanwell Health, Inc., a Delaware company, appears in BD’s fiscal 2025 subsidiary exhibit and among the expected subsidiaries of Augusta SpinCo Corporation, which BD combined with Waters Corporation on Feb 9, 2026. | Public record |
Read plainly: the technology cleared and worked, but the paperwork sits under the family manufacturer, not the startup; the pandemic product that made the company famous never got authorized; and the one that did belonged to the buyer and was pulled within two years.
What to watch
- Whether the platform resurfaces under Waters Corporation, which took the entity in February 2026.
- Whether K170118 is ever transferred or refiled under another name.
- The menu BD described on buying the company: COVID-19 with influenza A and B, group A strep, chronic disease monitoring. None has appeared.
- Any published output from the NIH funded kidney work, whose project ended in August 2023.
- The scanwellhealth.com domain, which as of September 2026 no longer carries the company site.
In their words
“I come from a family that manufactures pee-tests,”
Stephen Chen, founder and CEO, TechCrunch · Independent
“The core chemistry is a traditional diagnostics kit that has been used by the healthcare system for many years,”
Stephen Chen, TechCrunch, 2019 · Independent
“We’ve taken that standalone box and moved it to the smartphone.”
Stephen Chen, TechCrunch, 2019 · Independent
“The strips you buy over the counter are purely subjective because you are relying on lay people to read them”
Stephen Chen, 360Dx, 2018 · Independent
“Paper tests are so cheap. They can reach people through the mail. It’s kind of like when AOL used to send out a bunch of discs.”
Stephen Chen, TechCrunch, 2018 · Independent
“Before Scanwell Health, virtual visits for UTIs relied on patient-reported symptoms for diagnosis,”
Jack Jeng, chief medical officer, Fierce Biotech · Independent
“But given all the ups and downs these past few weeks I’m going to remain cautiously optimistic until the supplies are actually in our possession,”
Jack Jeng, Business Insider, April 2020 · Independent
“The COVID-19 pandemic has accelerated the shift to new care settings, and BD is ready to deliver a smart, connected at-home diagnostic ecosystem to support traditional and telehealth providers and consumers,”
Dave Hickey, Life Sciences president, BD, December 2021 · Company release
Related companies
Sources
- Public recordFDA 510(k) letter and summary, K170118
- Public recordFDA 510(k) database
- Public recordRevocation of Eleven Emergency Use Authorizations
- Public recordNIH RePORTER R44ES032768
- Public recordBecton Dickinson Form 10-Q
- Public recordBecton Dickinson Form 10-K subsidiary exhibits
- Public recordExhibit 21.1, Augusta SpinCo Corporation subsidiaries
- IndependentA direct-to-consumer urine-testing app with FDA clearance
- IndependentSmartphone Urinalysis Firms Aim for Clinical-Grade Testing
- IndependentScanwell launches smartphone UTI tests with Lemonaid
- IndependentScanwell launches home smartphone test for UTIs
- IndependentScanwell moves beyond UTI testing to kidney disease
- IndependentScanwell aims to launch a 15-minute home coronavirus test
- IndependentA startup’s struggle to make the first home antibody test
- IndependentUnauthorized home COVID test kits targeted by FDA
- IndependentBD acquires COVID test partner Scanwell Health
- CompanyScanwell to Launch Clinical-Grade Rapid At-Home Test
- CompanyBD Receives Emergency Use Authorization
- CompanyBD Acquires Scanwell Health, Inc.
- CompanyBD Completes Combination with Waters
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
