Cleared Traditional

BECKMAN LIQUID STAT LIQUID/ALKALINE PHO (K802574) - FDA 510(k) Clearance

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

K802574 · Beckman Instruments, Inc. · Chemistry device
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Nov 1980
Decision
26d
Days
Class 2
Risk

K802574 is an FDA 510(k) clearance for the BECKMAN LIQUID STAT LIQUID/ALKALINE PHO. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 K802574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1980
Decision Date November 12, 1980
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 34
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K802574.
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · Sigma Diagnostics, Inc. · Jun 1984
PARAMAX ALKALINE PHOSPHATASE REAGENT-
K831480 · American Dade · Jun 1983
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
K823213 · Boehringer Mannheim Corp. · Nov 1982
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · Beckman Instruments, Inc. · Sep 1978
MULTISTAT III ALKALINE PHOSPHATASE
K771470 · Instrumentation Laboratory CO · Sep 1977
SIGMA PROCED #SC165
K760685 · Sigma Chemical Co. · Nov 1976