Cleared Traditional

K930306 - COBAS CORE LH EIA

K930306 is an FDA 510(k) clearance for COBAS CORE LH EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K930306 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
125d
Days
Class 1
Risk

K930306 is an FDA 510(k) clearance for the COBAS CORE LH EIA. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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.

FDA 510(k) Submission Details - K930306

510(k) Number K930306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date May 26, 1993
Days to Decision 125 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
36d slower than avg
Panel avg: 89d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 134
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K930306.
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
ONE STEP LH TEST
K935134 · Tcpi, Inc. · Jan 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
K930185 · Princeton Biomedix · Mar 1993
IMMUCHEM LH-MW ELISA
K922944 · Icn Biomedicals, Inc. · Feb 1993
ELISA TUBE LH TEST KIT
K920920 · Bio Clinic Co. · Apr 1992
K930306 · COBAS CORE LH EIA
Download PDF Roche Diagnostic Syst…