Cleared Traditional

K932409 - SAS(TM) SERUM/URINE HCG

K932409 is the FDA 510(k) clearance for SAS(TM) SERUM/URINE HCG by Sa Scientific, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K932409 · Sa Scientific, Inc. · Chemistry device
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Jun 1993
Decision
42d
Days
Class 2
Risk

K932409 is an FDA 510(k) clearance for the SAS(TM) SERUM/URINE HCG. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 42 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 K932409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date June 29, 1993
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHA System, Test, 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 - DHA System, Test, Human Chorionic Gonadotropin

All 39
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K932409.
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
K961351 · Bayer Corp. · Jun 1996
AURAFLEX HCG
K945331 · Organon Teknika Corp. · Mar 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · Princeton BioMeditech Corp. · Mar 1995
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · Baxter Diagnostics, Inc. · Oct 1992
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · Baxter Healthcare Corp · Aug 1991
STATUS HCG FLUOROMETRIC ENZYME
K893577 · Baxter Healthcare Corp · Aug 1989