Cleared Traditional

K922073 - STRATUS BHCG FLUOROMETRIC ENZYME IMMUNO...

K922073 is the FDA 510(k) clearance for STRATUS BHCG FLUOROMETRIC ENZYME IMMUNO... by Baxter Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K922073 · Baxter Diagnostics, Inc. · Chemistry device
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Oct 1992
Decision
168d
Days
Class 2
Risk

K922073 is an FDA 510(k) clearance for the STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on October 19, 1992 after a review of 168 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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K922073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date October 19, 1992
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
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 42
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K922073.
AURAFLEX HCG
K945331 · Organon Teknika Corp. · Mar 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · Princeton BioMeditech Corp. · Mar 1995
SAS(TM) SERUM/URINE HCG
K932409 · Sa Scientific, Inc. · Jun 1993
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · Baxter Healthcare Corp · Aug 1991
STATUS HCG FLUOROMETRIC ENZYME
K893577 · Baxter Healthcare Corp · Aug 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · Leeco Diagnostics, Inc. · Jun 1989