Cleared Traditional

K812650 - BECKMAN ICS NORMAL CONTROL SERA

K812650 is an FDA 510(k) clearance for BECKMAN ICS NORMAL CONTROL SERA, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K812650 · Beckman Instruments, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K812650

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.

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 487
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K812650.
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
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ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167 · Ortho Diagnostic Systems, Inc. · Nov 1981
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
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BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · American Dade · Sep 1981
HELENA FETAL-TEK 200 MARKER
K811695 · Helena Laboratories · Jul 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · Ortho Diagnostic Systems, Inc. · Jun 1981