Cleared Traditional

K964660 - PARAMAX CHOLESTEROL REAGENT

K964660 is the FDA 510(k) clearance for PARAMAX CHOLESTEROL REAGENT by Dade Intl., Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K964660 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
196d
Days
Class 1
Risk

K964660 is an FDA 510(k) clearance for the PARAMAX CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 196 days - an extended review cycle.

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 Dade Intl., Inc. devices

Submission Details

510(k) Number K964660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date June 04, 1997
Days to Decision 196 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
108d slower than avg
Panel avg: 88d · This submission: 196d
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 122
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K964660.
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · Roche Diagnostic Systems, Inc. · Dec 1997
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
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · Boehringer Mannheim Corp. · Mar 1996
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · Data Medical Associates, Inc. · Aug 1995