Cleared Traditional

K922073 - STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY

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

K922073 · Baxter Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K922073

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
79d slower than avg
Panel avg: 89d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K922073.
SEALITE SCIENCES INC.
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UNISTEP HCG PREGNANCY TEST STRIP
K941090 · Biotech Atlantic, Inc. · Jun 1994
SAS(TM) SERUM/URINE HCG
K932409 · Sa Scientific, Inc. · Jun 1993
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · Baxter Healthcare Corp · Aug 1991
IMMULITE(TM) HCG
K911796 · Cirrus Diagnostics, Inc. · Jun 1991
SINGLE AND DUAL BAND DIPSTICK HCG TEST
K893873 · Ampcor, Inc. · Aug 1989
K922073 · STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
Download PDF FDA Summary Baxter Diagnostics, I…