Cleared Traditional

K922612 - CHOLESTECH LIPID MONITORING SYSTEM

K922612 is an FDA 510(k) clearance for CHOLESTECH LIPID MONITORING SYSTEM, manufactured by Cholestech Corp.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K922612 · Cholestech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
22d
Days
Class 1
Risk

K922612 is an FDA 510(k) clearance for the CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on June 24, 1992 after a review of 22 days - a notably fast clearance 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: 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 Cholestech Corp. devices

FDA 510(k) Submission Details - K922612

510(k) Number K922612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date June 24, 1992
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 172
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K922612.
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
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · Em Diagnostic Systems, Inc. · Dec 1991
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469 · Cholestech Corp. · Oct 1991
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · King Diagnostics, Inc. · Sep 1991