Cleared Traditional

K990282 - ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL

K990282 is the FDA 510(k) clearance for ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K990282 · Bio-Rad · Chemistry device
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Mar 1999
Decision
39d
Days
Class 1
Risk

K990282 is an FDA 510(k) clearance for the ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on March 9, 1999 after a review of 39 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 Bio-Rad devices

Submission Details

510(k) Number K990282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date March 09, 1999
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K990282.
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
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K984477 · Bio-Rad · Jan 1999