Cleared Traditional

K943195 - COAT-A-COUNT NEONATAL TSH IRMA

K943195 is the FDA 510(k) clearance for COAT-A-COUNT NEONATAL TSH IRMA by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K943195 · Diagnostic Products Corp. · Chemistry device
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Mar 1995
Decision
251d
Days
Class 2
Risk

K943195 is an FDA 510(k) clearance for the COAT-A-COUNT NEONATAL TSH IRMA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 251 days - an extended review cycle.

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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K943195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date March 13, 1995
Days to Decision 251 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 88d · This submission: 251d
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 125
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K943195.
AXSYM ULTRASENSITIVE HTSH II
K952148 · Abbott Laboratories · Jun 1995
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
K951796 · Ciba Corning Diagnostics Corp. · Jun 1995
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
K950921 · Nichols Institute Diagnostics · May 1995
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · Diagnostic Products Corp. · Dec 1994