Cleared Traditional

K841053 - CHOLESTEROL REAGENT SET ENZYMATIC

K841053 is the FDA 510(k) clearance for CHOLESTEROL REAGENT SET ENZYMATIC by Medical Specialties, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841053 · Medical Specialties, Inc. · Chemistry device
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May 1984
Decision
50d
Days
Class 1
Risk

K841053 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT SET ENZYMATIC. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 50 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 Medical Specialties, Inc. devices

Submission Details

510(k) Number K841053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date May 01, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 121
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K841053.
CHOLESTEROL ASSSAY KIT
K842160 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
TDX REA CHOLESTEROL
K842320 · Abbott Laboratories · Aug 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182 · Beckman Instruments, Inc. · May 1984
PARAMAX CHOLESTEROL REAGENT
K840776 · American Dade · Apr 1984
DURAZYME CHOLESTEROL
K840368 · American Monitor Corp. · Mar 1984
FLOW-PAC SHOLESTEROL REAGENT SET
K832780 · American Research Products Co. · Oct 1983