Cleared Traditional

K924508 - CHOLESTEROL TEST ITEM# 42374/93

K924508 is the FDA 510(k) clearance for CHOLESTEROL TEST ITEM# 42374/93 by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K924508 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
146d
Days
Class 1
Risk

K924508 is an FDA 510(k) clearance for the CHOLESTEROL TEST ITEM# 42374/93, 42322/R1. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 146 days - within the typical 510(k) review window.

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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K924508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date January 28, 1993
Days to Decision 146 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
58d slower than avg
Panel avg: 88d · This submission: 146d
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 K924508.
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · Randox Laboratories, Ltd. · Jan 1994
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS CHOLESTEROL REAGENT
K925603 · Olympus Corp. · Feb 1993
OLYMPUS CHOLESTEROL REAGENT
K922231 · Olympus Corp. · Nov 1992
CHOLESTEROL TEST
K923733 · Em Diagnostic Systems, Inc. · Oct 1992
KING DIAGNOSTICS CHOLESTEROL REAGENT
K923128 · King Diagnostics, Inc. · Sep 1992