Cleared Traditional

K893577 - STATUS HCG FLUOROMETRIC ENZYME

K893577 is an FDA 510(k) clearance for STATUS HCG FLUOROMETRIC ENZYME, manufactured by Baxter Healthcare Corp. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K893577 · Baxter Healthcare Corp · Chemistry device
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Aug 1989
Decision
86d
Days
Class 2
Risk

K893577 is an FDA 510(k) clearance for the STATUS HCG FLUOROMETRIC ENZYME. 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 3, 1989 after a review of 86 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.

FDA 510(k) Submission Details - K893577

510(k) Number K893577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date August 03, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 89d · This submission: 86d
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 K893577.
IMMULITE(TM) HCG
K911796 · Cirrus Diagnostics, Inc. · Jun 1991
SINGLE AND DUAL BAND DIPSTICK HCG TEST
K893873 · Ampcor, Inc. · Aug 1989
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
K893953 · Totem Diagnostics, Inc. · Aug 1989
BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST
K892654 · Princeton Biomedix · Jun 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · Leeco Diagnostics, Inc. · Jun 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · Leeco Diagnostics, Inc. · Jun 1989
K893577 · STATUS HCG FLUOROMETRIC ENZYME
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