Cleared Traditional

K973284 - COBAS INTEGRA HDL-CHOLESTEROL DIRECT

K973284 is the FDA 510(k) clearance for COBAS INTEGRA HDL-CHOLESTEROL DIRECT by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K973284 · Roche Diagnostic Systems, Inc. · Chemistry device
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Dec 1997
Decision
107d
Days
Class 1
Risk

K973284 is an FDA 510(k) clearance for the COBAS INTEGRA HDL-CHOLESTEROL DIRECT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 K973284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date December 18, 1997
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 107
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K973284.
CHOL
K981652 · Abbott Laboratories · Jun 1998
CHOL
K981476 · Abbott Laboratories · Jun 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667 · Sigma Diagnostics, Inc. · Apr 1998
CHOLESTEROL RAPID LIQUID REAGENT
K972853 · Reagents Applications, Inc. · Sep 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · Beckman Instruments, Inc. · Jun 1997
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · Trace Scientific , Ltd. · Sep 1996