Cleared Traditional

K940006 - IMMULITE THIRD GENERATION (MODIFICATION)

K940006 is an FDA 510(k) clearance for IMMULITE THIRD GENERATION (MODIFICATION), manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K940006

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.

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 198
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K940006.
NEOSCREEN ELISA TSH
K942658 · Pantex, Div. Bio-Analysis, Inc. · Feb 1995
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
K941146 · Dupont Medical Products · Oct 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · Abbott Laboratories · Aug 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · Abbott Laboratories · Jun 1994