Cleared Traditional

K935863 - SAS(TM) DIRECT MONOCLONAL HCG

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

K935863 · Sa Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 28
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K935863.
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
CLEARVIEW HCG
K910946 · Unipath , Ltd. · Apr 1991
PREGNOSPIA II
K881435 · Organon Teknika Corp. · May 1988
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988
PREGNASLIDE
K863198 · Armkel, LLC · Sep 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · Leeco Diagnostics, Inc. · Jul 1986