Cleared Traditional

K946161 - DMA TOTAL CHOLESTEROL PROCEDURE

K946161 is an FDA 510(k) clearance for DMA TOTAL CHOLESTEROL PROCEDURE, manufactured by Data Medical Associates, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K946161 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
247d
Days
Class 1
Risk

K946161 is an FDA 510(k) clearance for the DMA TOTAL CHOLESTEROL PROCEDURE. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on August 23, 1995 after a review of 247 days - an extended review 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: 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 Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K946161

510(k) Number K946161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date August 23, 1995
Days to Decision 247 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
159d slower than avg
Panel avg: 88d · This submission: 247d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 186
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K946161.
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · Trace Scientific , Ltd. · Sep 1996
ENA-C-T TOTAL CHOLESTEROL TEST
K960377 · Actimed Laboratories, Inc. · May 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · Boehringer Mannheim Corp. · Mar 1996
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · Abaxis, Inc. · Apr 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063 · Cholestech Corp. · Feb 1995