Cleared Traditional

K940006 - IMMULITE THIRD GENERATION (MODIFICATION)

K940006 is the FDA 510(k) clearance for IMMULITE THIRD GENERATION (MODIFICATION) by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K940006 · Diagnostic Products Corp. · Chemistry device
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Dec 1994
Decision
347d
Days
Class 2
Risk

K940006 is an FDA 510(k) clearance for the IMMULITE THIRD GENERATION (MODIFICATION). 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 347 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K940006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1994
Decision Date December 19, 1994
Days to Decision 347 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
259d slower than avg
Panel avg: 88d · This submission: 347d
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 K940006.
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · Diagnostic Products Corp. · Mar 1995
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · Abbott Laboratories · Aug 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · Abbott Laboratories · Jun 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
K935119 · Bio-Rad · Apr 1994