Cleared Traditional

STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO (K912852) - FDA 510(k) Clearance

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

K912852 · Baxter Healthcare Corp · Chemistry device
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Sep 1991
Decision
91d
Days
Class 2
Risk

K912852 is an FDA 510(k) clearance for the STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Healthcare Corp devices

Submission Details

510(k) Number K912852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date September 27, 1991
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 58
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K912852.
VISTA ULTRASENSITIVE HTSH ASSAY
K922138 · Syva Co. · Jul 1992
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
K922736 · Eastman Kodak Company · Jul 1992
ENZYMUN-TEST TSH
K915195 · Boehringer Mannheim Corp. · Feb 1992
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · Baxter Healthcare Corp · Jun 1991
NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
K912324 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1991
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · Bio-Rad · Sep 1990