Cleared Traditional

K802153 - CBC PAP TEST KIT

K802153 is an FDA 510(k) clearance for CBC PAP TEST KIT, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K802153 · Calbiochem-Behring Corp. · Chemistry device
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Nov 1980
Decision
65d
Days
Class 2
Risk

K802153 is an FDA 510(k) clearance for the CBC PAP TEST KIT. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - 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 Calbiochem-Behring Corp. devices

FDA 510(k) Submission Details - K802153

510(k) Number K802153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date November 12, 1980
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFH Device Classification - Class 2, Special Controls

Product Code JFH Acid Phosphatase (prostatic), Tartrate Inhibited
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 34
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K802153.
LEECO P.A.P. - QUANT DIAGNOSTIC KIT
K810232 · Leeco Diagnostics, Inc. · Feb 1981
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-
K802886 · Nuclear Diagnostics, Inc. · Jan 1981
RIAPHASE (125I) PROST. ACID PHOSPH. KIT
K803043 · Beckman Instruments, Inc. · Jan 1981
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · Leeco Diagnostics, Inc. · Jan 1980
ELVI ACID & PROSTATIC PHOSPHATASE
K792405 · Volu Sol Medical Industries · Dec 1979
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497 · Clinical Assays, Inc. · Dec 1979