Cleared Traditional

COMP. CLIN. CHEM. REF. SERUM-BENCHMARK (K780553) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K780553 · Beckman Instruments, Inc. · Chemistry device
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May 1978
Decision
44d
Days
Class 2
Risk

K780553 is an FDA 510(k) clearance for the COMP. CLIN. CHEM. REF. SERUM-BENCHMARK. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K780553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1978
Decision Date May 19, 1978
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 106
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K780553.
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · Boehringer Mannheim Corp. · Apr 1981
GAL-PUT CONTROLS, NORMAL&DEFICIENT
K800910 · Sigma Chemical Co. · Apr 1980
PRINCIPAL ANALYTE REFERENCE SERUM
K792384 · Beckman Instruments, Inc. · Dec 1979
SMA REFERENCE SERUM 3
K770142 · Technicon Instruments Corp. · Feb 1977