Cleared Traditional

K801988 - NORDICLAB PROSTATIC ACID PHOSPHATASE RIA

K801988 is the FDA 510(k) clearance for NORDICLAB PROSTATIC ACID PHOSPHATASE RIA by Nordiclab Intl.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K801988 · Nordiclab Intl. · Chemistry device

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Sep 1980

Decision

38d

Days

Class 2

Risk

K801988 is an FDA 510(k) clearance for the NORDICLAB PROSTATIC ACID PHOSPHATASE RIA. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Nordiclab Intl. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 38 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 Nordiclab Intl. devices

Submission Details

510(k) Number	K801988 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 1980
Decision Date	September 26, 1980
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

50d faster than avg

Panel avg: 88d · This submission: 38d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 29

Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K801988.

LEECO P.A.P. - QUANT DIAGNOSTIC KIT

K810232 · Leeco Diagnostics, Inc. · Feb 1981

RIAPHASE (125I) PROST. ACID PHOSPH. KIT

K803043 · Beckman Instruments, Inc. · Jan 1981

CBC PAP TEST KIT

K802153 · Calbiochem-Behring Corp. · Nov 1980

LEECO P.A.P. QUANT. DIAGNOSTIC KIT

K792652 · Leeco Diagnostics, Inc. · Jan 1980

ELVI ACID & PROSTATIC PHOSPHATASE

K792405 · Volu Sol Medical Industries · Dec 1979

P.A.P. TEST KIT, RIA-ZYME

K790040 · Mallinckrodt Critical Care · Apr 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K801988

Nordiclab Intl.

Mchenry, IL · US

Regulatory profile

8 submissions 8 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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