Cleared Traditional

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K913236) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913236 · Baxter Healthcare Corp · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
25d
Days
Class 2
Risk

K913236 is an FDA 510(k) clearance for the STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1155 - the FDA toxicology device 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K913236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date August 16, 1991
Days to Decision 25 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · This submission: 25d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DHA System, Test, Human Chorionic Gonadotropin

All 26
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K913236.
ABBOTT ARCHEITECT TOTAL B-HCG
K983424 · Abbott Laboratories · Dec 1998
ELECSYS HCG ASSAY
K961487 · Boehringer Mannheim Corp. · Jun 1996
SAS(TM) SERUM/URINE HCG
K932409 · Sa Scientific, Inc. · Jun 1993
STATUS HCG FLUOROMETRIC ENZYME
K893577 · Baxter Healthcare Corp · Aug 1989
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · Abbott Laboratories · Dec 1988
ENZYMUN-TEST HCG
K862108 · Boehringer Mannheim Corp. · Aug 1986