Cleared Traditional

BECKMAN ICS NORMAL CONTROL SERA (K812650) - FDA 510(k) Clearance

Class I Chemistry device.

K812650 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
32d
Days
Class 1
Risk

K812650 is an FDA 510(k) clearance for the BECKMAN ICS NORMAL CONTROL SERA. 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 October 19, 1981 after a review of 32 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 K812650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1981
Decision Date October 19, 1981
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K812650.
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242 · Beckman Instruments, Inc. · May 1982
Q-LINE LTC
K813580 · Miles Laboratories, Inc. · Jan 1982
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
K812556 · American Dade · Nov 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · American Dade · Sep 1981
HELENA FETAL-TEK 200 MARKER
K811695 · Helena Laboratories · Jul 1981
KEMTROL SERUM CONTROL-NORMAL
K802108 · Helena Laboratories · Oct 1980