Cleared Traditional

K811757 - NEIA PAP ENZYMEIMMUNOASSAY

K811757 is an FDA 510(k) clearance for NEIA PAP ENZYMEIMMUNOASSAY, manufactured by New England Immunology Assoc.. The device is a Class 2 Immunology device with product code JFH cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K811757 · New England Immunology Assoc. · Immunology device
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Aug 1981
Decision
52d
Days
Class 2
Risk

K811757 is an FDA 510(k) clearance for the NEIA PAP ENZYMEIMMUNOASSAY. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by New England Immunology Assoc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1020 - the FDA immunology device 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.

FDA 510(k) Submission Details - K811757

510(k) Number K811757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date August 13, 1981
Days to Decision 52 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 105d · This submission: 52d
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 Immunology devices follow this clearance model.

Regulatory Peers - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 38
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K811757.
ABBOTT PAP-EIA
K812925 · Abbott Laboratories · Jan 1982
RIAGEN PAP RIA
K813261 · Biogenex Laboratories · Dec 1981
TANDEM PAP KIT - (PARTS I & II)
K811959 · Hybritech, Inc. · Sep 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
K811169 · Amersham Corp. · May 1981
ESKACHEM PAP REAGENT
K803234 · Smithkline Diagnostics, Inc. · Feb 1981
K811757 · NEIA PAP ENZYMEIMMUNOASSAY
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