Cleared Traditional

K863851 - ACID PHOSPHATASE (ACP) REAGENT

K863851 is the FDA 510(k) clearance for ACID PHOSPHATASE (ACP) REAGENT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CKB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K863851 · Sigma Diagnostics, Inc. · Chemistry device
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Oct 1986
Decision
14d
Days
Class 2
Risk

K863851 is an FDA 510(k) clearance for the ACID PHOSPHATASE (ACP) REAGENT. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 14 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K863851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1986
Decision Date October 16, 1986
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CKB Acid Phosphatase, Naphthyl Phosphate
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 - CKB Acid Phosphatase, Naphthyl Phosphate

All 16
Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K863851.
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
K884747 · Technicon Instruments Corp. · Jan 1989
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · Sclavo, Inc. · Apr 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988
ACID PHOSPHATASE PROCEDURE
K861675 · Data Medical Associates, Inc. · May 1986
DATA ZYME ACID PHOSPHATASE PROCEDURE
K850902 · Data Medical Associates, Inc. · Mar 1985
PARAMAX ACID PHOSPHATASE REAGENT
K840661 · American Dade · Apr 1984