Cleared Traditional

K933212 - IMMULITE RAPID TSH

K933212 is the FDA 510(k) clearance for IMMULITE RAPID TSH by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 570-day FDA review.

K933212 · Diagnostic Products Corp. · Chemistry device
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Dec 1994
Decision
570d
Days
Class 2
Risk

K933212 is an FDA 510(k) clearance for the IMMULITE RAPID TSH. 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 December 19, 1994 after a review of 570 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K933212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date December 19, 1994
Days to Decision 570 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
482d slower than avg
Panel avg: 88d · This submission: 570d
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 K933212.
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
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · Diagnostic Products Corp. · Mar 1995
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · Diagnostic Products Corp. · Dec 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · Abbott Laboratories · Aug 1994