Cleared Traditional

K923286 - STRATUS FOLATE FLUOROMETRIC ENZYME-LINK...

K923286 is the FDA 510(k) clearance for STRATUS FOLATE FLUOROMETRIC ENZYME-LINK... by Baxter Diagnostics, Inc.. It is a Class 2 Toxicology device (product code CGN) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K923286 · Baxter Diagnostics, Inc. · Toxicology device
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Sep 1992
Decision
73d
Days
Class 2
Risk

K923286 is an FDA 510(k) clearance for the STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1295 - 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 Diagnostics, Inc. devices

Submission Details

510(k) Number K923286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date September 17, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 87d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K923286.
VISTA FOLATE ASSAY
K934121 · Syva Co. · Oct 1993
ACCESS FOLATE ASSAY
K932887 · Beckman Coulter, Inc. · Oct 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · Bio-Rad · Oct 1993
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
K922823 · Bio-Rad Laboratories, Inc. · Aug 1992
MILENIA FOLIC ACID
K921614 · Diagnostic Products Corp. · Jun 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
K921689 · Microgenics Corp. · Jun 1992