Cleared Traditional

K972853 - CHOLESTEROL RAPID LIQUID REAGENT

K972853 is the FDA 510(k) clearance for CHOLESTEROL RAPID LIQUID REAGENT by Reagents Applications, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K972853 · Reagents Applications, Inc. · Chemistry device
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Sep 1997
Decision
89d
Days
Class 1
Risk

K972853 is an FDA 510(k) clearance for the CHOLESTEROL RAPID LIQUID REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on September 24, 1997 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reagents Applications, Inc. devices

Submission Details

510(k) Number K972853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1997
Decision Date September 24, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 88d · This submission: 89d
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 126
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K972853.
CHOL
K981476 · Abbott Laboratories · Jun 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667 · Sigma Diagnostics, Inc. · Apr 1998
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · Roche Diagnostic Systems, Inc. · Dec 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