Cleared Traditional

K935863 - SAS(TM) DIRECT MONOCLONAL HCG

K935863 is an FDA 510(k) clearance for SAS(TM) DIRECT MONOCLONAL HCG, manufactured by Sa Scientific, Inc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K935863 · Sa Scientific, Inc. · Chemistry device
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Feb 1994
Decision
83d
Days
Class 2
Risk

K935863 is an FDA 510(k) clearance for the SAS(TM) DIRECT MONOCLONAL HCG. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 83 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 Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K935863

510(k) Number K935863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date February 24, 1994
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
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 K935863.
PREGNACOL PREGNANCY TEST
K972606 · Immunostics Inc., · Aug 1997
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968 · Tech-Co, Inc. · Jun 1996
ACCUTEX BETA-HCG TEST
K926112 · J.S. Medical Assoc. · Jul 1993
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