Cleared Traditional

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (K930006) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930006 · Bio-Chem Laboratory Systems, Inc. · Chemistry device
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Sep 1993
Decision
248d
Days
Class 2
Risk

K930006 is an FDA 510(k) clearance for the AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bio-Chem Laboratory Systems, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 248 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 Bio-Chem Laboratory Systems, Inc. devices

Submission Details

510(k) Number K930006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1993
Decision Date September 09, 1993
Days to Decision 248 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 88d · This submission: 248d
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 59
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K930006.
AXSYM ULTRASENSITIVE HTSH
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K935119 · Bio-Rad · Apr 1994
COBAS CORE TSH EIA
K930776 · Roche Diagnostic Systems, Inc. · Dec 1993
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · Sigma Chemical Co. · Aug 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · Bio-Rad · Jun 1993
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
K922701 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992