Cleared Traditional

K000810 - QUALITROL LIPID CONTROL, LEVELS 1 AND 2

K000810 is an FDA 510(k) clearance for QUALITROL LIPID CONTROL, manufactured by Consolidated Technologies of Wisconsin. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K000810 · Consolidated Technologies of Wisconsin · Chemistry device
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Apr 2000
Decision
31d
Days
Class 1
Risk

K000810 is an FDA 510(k) clearance for the QUALITROL LIPID CONTROL, LEVELS 1 AND 2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Consolidated Technologies of Wisconsin (Austin, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Consolidated Technologies of Wisconsin devices

FDA 510(k) Submission Details - K000810

510(k) Number K000810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date April 13, 2000
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K000810.
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632 · Avl Scientific Corp. · Jun 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · Bio-Rad · May 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875 · Bio-Rad · Apr 2000
ELECSYS CORTISOL TEST SYSTEM
K000270 · Roche Diagnostics Corp. · Mar 2000
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116 · Consolidated Technologies, Inc. · Feb 2000
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
K981915 · The Binding Site, Ltd. · Dec 1999