Cleared Traditional

K872728 - BINAX IRMA TOTAL BETA-HCG TEST KIT

K872728 is the FDA 510(k) clearance for BINAX IRMA TOTAL BETA-HCG TEST KIT by Binax, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K872728 · Binax, Inc. · Chemistry device
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Aug 1987
Decision
28d
Days
Class 2
Risk

K872728 is an FDA 510(k) clearance for the BINAX IRMA TOTAL BETA-HCG TEST KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on August 5, 1987 after a review of 28 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.

View all Binax, Inc. devices

Submission Details

510(k) Number K872728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date August 05, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 164
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K872728.
RESULT PLUS/HCG PREGNANCY TEST
K872730 · Ortho Diagnostic Systems, Inc. · Oct 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
K872390 · Nichols Institute Diagnostics · Sep 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · Syva Co. · Jul 1987
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · Hybritech, Inc. · Jun 1987