Cleared Traditional

K926112 - ACCUTEX BETA-HCG TEST

K926112 is an FDA 510(k) clearance for ACCUTEX BETA-HCG TEST, manufactured by J.S. Medical Assoc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K926112 · J.S. Medical Assoc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
237d
Days
Class 2
Risk

K926112 is an FDA 510(k) clearance for the ACCUTEX BETA-HCG TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 237 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J.S. Medical Assoc. devices

FDA 510(k) Submission Details - K926112

510(k) Number K926112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date July 28, 1993
Days to Decision 237 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 54
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K926112.
PREGNACOL PREGNANCY TEST
K972606 · Immunostics Inc., · Aug 1997
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968 · Tech-Co, Inc. · Jun 1996
SAS(TM) DIRECT MONOCLONAL HCG
K935863 · Sa Scientific, Inc. · Feb 1994
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
DIRECT PREGNANCY TEST
K920716 · Tech-Co, Inc. · Mar 1992
CLEARVIEW HCG
K910946 · Unipath , Ltd. · Apr 1991