Cleared Traditional

K875131 - (SKD) CHOLESTEROL TEST KIT

K875131 is the FDA 510(k) clearance for (SKD) CHOLESTEROL TEST KIT by Smithkline Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K875131 · Smithkline Diagnostics, Inc. · Chemistry device
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Mar 1988
Decision
77d
Days
Class 1
Risk

K875131 is an FDA 510(k) clearance for the (SKD) CHOLESTEROL TEST KIT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Smithkline Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 77 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K875131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date March 01, 1988
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
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 K875131.
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · Em Diagnostic Systems, Inc. · Feb 1989
HDL-CHOLESTEROL PRECIPITATING REAGENT
K883543 · Medical Analysis Systems, Inc. · Dec 1988
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
K883844 · Hichem Diagnostics · Oct 1988
WAKO(TM) AUTOKIT CHOLESTEROL
K880311 · Wako Chemicals USA, Inc. · Mar 1988
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · Biotrol, USA, Inc. · Aug 1987
CHOLESTEROL REAGENT
K872295 · Sigma Diagnostics, Inc. · Jul 1987