Cleared Traditional

K930776 - COBAS CORE TSH EIA

K930776 is the FDA 510(k) clearance for COBAS CORE TSH EIA by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K930776 · Roche Diagnostic Systems, Inc. · Chemistry device
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Dec 1993
Decision
290d
Days
Class 2
Risk

K930776 is an FDA 510(k) clearance for the COBAS CORE TSH EIA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 290 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K930776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date December 03, 1993
Days to Decision 290 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
202d slower than avg
Panel avg: 88d · This submission: 290d
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 133
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K930776.
IMX ULTRASENSISTIVE HTSH II
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K934410 · Abbott Laboratories · Jun 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
K935119 · Bio-Rad · Apr 1994
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · Sigma Chemical Co. · Aug 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · Bio-Rad · Jun 1993
ACCESS HTSH ASSAY
K925637 · Bio-Rad Laboratories, Inc. · Mar 1993