Cleared Traditional

RESPONSE LIQUID LIGAND ASSAY SERUM (K821242) - FDA 510(k) Clearance

Class I Chemistry device.

K821242 · Beckman Instruments, Inc. · Chemistry device
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May 1982
Decision
22d
Days
Class 1
Risk

K821242 is an FDA 510(k) clearance for the RESPONSE LIQUID LIGAND ASSAY SERUM. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K821242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1982
Decision Date May 21, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
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.

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 183
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K821242.
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K812556 · American Dade · Nov 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650 · Beckman Instruments, Inc. · Oct 1981