Cleared Traditional

HDL EZ-TAB (K833160) - FDA 510(k) Clearance

Class I Chemistry device.

K833160 · Preventive Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
146d
Days
Class 1
Risk

K833160 is an FDA 510(k) clearance for the HDL EZ-TAB. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1984 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 862.1475 - 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 Preventive Diagnostics Corp. devices

Submission Details

510(k) Number K833160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1983
Decision Date February 09, 1984
Days to Decision 146 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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 LBR Ldl & Vldl Precipitation, Hdl
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 - LBR Ldl & Vldl Precipitation, Hdl

All 10
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K833160.
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · Roche Diagnostic Systems, Inc. · Mar 1990
HDL CHOLESTEROL TEST
K885265 · Em Diagnostic Systems, Inc. · Feb 1989
IQ HDL CHOLESTEROL
K883353 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
LANCER HDL SEPARATION KIT
K790865 · Sherwood Medical Co. · Jun 1979
A-GENT-HDL REAGENT
K790329 · Abbott Laboratories · Apr 1979
HDL CENTRIFIKIT
K781093 · Beckman Instruments, Inc. · Aug 1978