Cleared Traditional

K912852 - STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO

K912852 is an FDA 510(k) clearance for STRATUS ULTRA-SENSIT HTSH FLUOR ENZYME ..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K912852 · Baxter Healthcare Corp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K912852

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.

JLW Device Classification - Class 2, Special Controls

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 202
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K912852.
VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
K920856 · Hycor Biomedical, Inc. · Mar 1992
ENZYMUN-TEST TSH
K915195 · Boehringer Mannheim Corp. · Feb 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · Medix Biotech, Inc. · Jan 1992
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · Ciba Corning Diagnostics Corp. · Aug 1991
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