Cleared Traditional

K811959 - TANDEM PAP KIT - (PARTS I & II)

K811959 is the FDA 510(k) clearance for TANDEM PAP KIT - (PARTS I & II) by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K811959 · Hybritech, Inc. · Chemistry device
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Sep 1981
Decision
54d
Days
Class 2
Risk

K811959 is an FDA 510(k) clearance for the TANDEM PAP KIT - (PARTS I & II). Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1981 after a review of 54 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 Hybritech, Inc. devices

Submission Details

510(k) Number K811959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1981
Decision Date September 01, 1981
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
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 28
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K811959.
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
K831670 · Ortho Diagnostic Systems, Inc. · Aug 1983
CORDIA PAP
K831105 · Cordis Corp. · May 1983
ABBOTT PAP-EIA
K812925 · Abbott Laboratories · Jan 1982
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