Cleared Traditional

BOEHRINGER MANNHEIM CHOLESTEROL ASSAY (K952127) - FDA 510(k) Clearance

Class I Chemistry device.

K952127 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
73d
Days
Class 1
Risk

K952127 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM CHOLESTEROL ASSAY. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 73 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K952127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date July 20, 1995
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
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 61
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K952127.
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · Roche Diagnostic Systems, Inc. · Dec 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · Beckman Instruments, Inc. · Jun 1997
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · Boehringer Mannheim Corp. · Mar 1996
ROCHE REAGENT
K941573 · Roche Diagnostic Systems, Inc. · Oct 1994
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS CHOLESTEROL REAGENT
K925603 · Olympus Corp. · Feb 1993