Cleared Traditional

K930776 - COBAS CORE TSH EIA

K930776 is an FDA 510(k) clearance for COBAS CORE TSH EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K930776

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.

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 K930776.
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K923532 · Solarcare Technologies Corp,Inc. · Mar 1993