Cleared Traditional

HDL CHOLESTEROL AQUEOUS STANDARDS (K840220) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840220 · Preventive Diagnostics Corp. · Chemistry device
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Mar 1984
Decision
64d
Days
Class 2
Risk

K840220 is an FDA 510(k) clearance for the HDL CHOLESTEROL AQUEOUS STANDARDS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Preventive Diagnostics Corp. (Walker, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Preventive Diagnostics Corp. devices

Submission Details

510(k) Number K840220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date March 23, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 46
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K840220.
80 MG/DL GLUCOSE CONTROL
K844581 · Boehringer Mannheim Corp. · Dec 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · Roche Diagnostic Systems, Inc. · Sep 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984
PRECISET CHOLESTEROL HIGH PERFORM
K832251 · Boehringer Mannheim Corp. · Aug 1983
ACA URINARY PROTEIN CALIBRATOR
K822232 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1982
SYVA ADVANCE STANDARDIZATION KIT #2
K821937 · Syva Co. · Jul 1982