Cleared Traditional

K923123 - HCG PREGNANCY ONE STEP TEST STRIP

K923123 is an FDA 510(k) clearance for HCG PREGNANCY ONE STEP TEST STRIP, manufactured by Tcpi, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K923123 · Tcpi, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
75d
Days
Class 2
Risk

K923123 is an FDA 510(k) clearance for the HCG PREGNANCY ONE STEP TEST STRIP. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Tcpi, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K923123

510(k) Number K923123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1992
Decision Date September 09, 1992
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 89d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K923123.
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259 · Medix Biotech, Inc. · Nov 1992
VISUAL HCG PREGNANCY TEST
K923376 · Tech-Co, Inc. · Oct 1992
ANI BIOCARD HCG TEST
K923030 · Ani OY · Sep 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · Vitek Systems, Inc. · Jul 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290 · American Medical Products, Inc. · Jul 1992
K923123 · HCG PREGNANCY ONE STEP TEST STRIP
Download PDF FDA Summary Tcpi, Inc.