Cleared Traditional

K896092 - ALKALINE PHOSPHATASE, LEUKOCYTE, KIT (FDA 510(k) Clearance)

Class I Hematology device.

K896092 · Sigma Chemical Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
21d
Days
Class 1
Risk

K896092 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE, LEUKOCYTE, KIT. Classified as Test, Leukocyte Alkaline Phosphatase (product code GHD), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on November 9, 1989 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7660 - the FDA hematology 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.

View all Sigma Chemical Co. devices

Submission Details

510(k) Number K896092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date November 09, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GHD Test, Leukocyte Alkaline Phosphatase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.