Cleared Traditional

K864945 - TANDEM M-PAK(TM) PAP IMMUNOENZYMETRIC A...

K864945 is the FDA 510(k) clearance for TANDEM M-PAK(TM) PAP IMMUNOENZYMETRIC A... by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K864945 · Hybritech, Inc. · Chemistry device
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Jan 1987
Decision
19d
Days
Class 2
Risk

K864945 is an FDA 510(k) clearance for the TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 19 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 K864945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1986
Decision Date January 05, 1987
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
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 K864945.
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · Baxter Healthcare Corp · Aug 1989
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
K884748 · Technicon Instruments Corp. · Jan 1989
ABBOTT PAP-EIA
K873903 · Abbott Laboratories · Dec 1987
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
K863832 · Pointe Scientific, Inc., · Dec 1986
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · Diagnostic Products Corp. · Sep 1985
TANDEM E PAP
K851950 · Hybritech, Inc. · Jun 1985