FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS— 510(k) K112101

Clearance details

Applicant

Polymed Therapeutics, Inc.

Product code

Code JHI

Device class

Class 2

Regulation

21 CFR 862.1155

Advisory panel

Clinical Chemistry

Date received

2011-07-22

Decision date

2012-07-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mission Viejo, CA, US

• K262299 — Instant-View® hCG Combo II Cassette Test2026-09-22
• K241919 — Innovita HCG Pregnancy Rapid Combo Test2024-08-02
• K203272 — Alltest Pregnancy Rapid Combo Test Cassette2022-01-31
• K172322 — Atellica IM Total hCG (ThCG)2018-03-29
• K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)2017-12-22

• K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)2014-09-25
• K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST2014-01-09
• K121065 — POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE2013-05-24
• K122907 — FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER2013-03-14

Malfunction

1,055

Total

1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2391-2018 — NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy testClass II·Terminated·Ekla Corporation·20161020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112101.