Cleared Traditional

K920829 - COBAS CORE FERRITIN EIA

K920829 is an FDA 510(k) clearance for COBAS CORE FERRITIN EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Immunology device with product code JMG cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K920829 · Roche Diagnostic Systems, Inc. · Immunology device
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Jun 1992
Decision
116d
Days
Class 2
Risk

K920829 is an FDA 510(k) clearance for the COBAS CORE FERRITIN EIA. Classified as Radioimmunoassay (two-site Solid Phase), Ferritin (product code JMG), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 19, 1992 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K920829

510(k) Number K920829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date June 19, 1992
Days to Decision 116 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 105d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JMG Device Classification - Class 2, Special Controls

Product Code JMG Radioimmunoassay (two-site Solid Phase), Ferritin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 Immunology devices follow this clearance model.

Regulatory Peers - JMG Radioimmunoassay (two-site Solid Phase), Ferritin

All 20
Devices cleared under the same product code (JMG) and FDA review panel - the closest regulatory comparables to K920829.
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CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138 · Baxter Healthcare Corp · Apr 1988