Cleared Traditional

K863832 - NAPHTHYL PHOSPHATE

K863832 is the FDA 510(k) clearance for NAPHTHYL PHOSPHATE by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K863832 · Pointe Scientific, Inc., · Chemistry device
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Dec 1986
Decision
77d
Days
Class 2
Risk

K863832 is an FDA 510(k) clearance for the NAPHTHYL PHOSPHATE, ACID PHOSPHATASE. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Detroit, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 77 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K863832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date December 16, 1986
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
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 K863832.
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
K884748 · Technicon Instruments Corp. · Jan 1989
ABBOTT PAP-EIA
K873903 · Abbott Laboratories · Dec 1987
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · Hybritech, Inc. · Jan 1987
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · Diagnostic Products Corp. · Sep 1985
TANDEM E PAP
K851950 · Hybritech, Inc. · Jun 1985
DSL PAP RIA -DSL#3100
K844679 · Diagnostic Systems Laboratories, Inc. · Apr 1985