Cleared Traditional

BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM (K801749) - FDA 510(k) Clearance

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

K801749 · Beckman Instruments, Inc. · Chemistry device
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Sep 1980
Decision
50d
Days
Class 2
Risk

K801749 is an FDA 510(k) clearance for the BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 K801749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date September 16, 1980
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - CEK Biuret (colorimetric), Total Protein

All 29
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K801749.
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913 · Technicon Instruments Corp. · May 1982
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028 · Eastman Kodak Company · Aug 1981
IL TOTAL PROTEIN REAGENT
K802310 · Instrumentation Laboratory CO · Oct 1980
MULTISTAT III TOTAL PROTEIN TEST
K771476 · Instrumentation Laboratory CO · Sep 1977