Cleared Traditional

LYPOPROTEIN CHOLESTEROL TEST KIT (K780173) - FDA 510(k) Clearance

Class I Chemistry device.

K780173 · Environmental Chemical Specialties · Chemistry device
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May 1978
Decision
90d
Days
Class 1
Risk

K780173 is an FDA 510(k) clearance for the LYPOPROTEIN CHOLESTEROL TEST KIT. Classified as Colorimetric Method, Lipoproteins (product code JHM), Class I - General Controls.

Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Environmental Chemical Specialties devices

Submission Details

510(k) Number K780173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1978
Decision Date May 03, 1978
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHM Colorimetric Method, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - JHM Colorimetric Method, Lipoproteins

All 8
Devices cleared under the same product code (JHM) and FDA review panel - the closest regulatory comparables to K780173.
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · Dade Behring, Inc. · Feb 2008
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
K032798 · Dade Behring, Inc. · Oct 2003
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
K983849 · Dade Behring, Inc. · Jan 1999
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935 · Roche Diagnostic Systems, Inc. · Sep 1990