Cleared Traditional

K880989 - ATS CRYPTOSPORIDIUM STAIN SET (FDA 510(k) Clearance)

Class I Pathology device.

K880989 · Alpha-Tec Systems, Inc. · Pathology device
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May 1988
Decision
66d
Days
Class 1
Risk

K880989 is an FDA 510(k) clearance for the ATS CRYPTOSPORIDIUM STAIN SET. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 Alpha-Tec Systems, Inc. devices

Submission Details

510(k) Number K880989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date May 13, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 77d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTS Stains, Microbiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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.