Cleared Traditional

K913133 - CHALITY CONTROL MATERIAL (ASSAYED & UNA...

K913133 is the FDA 510(k) clearance for CHALITY CONTROL MATERIAL (ASSAYED & UNA... by Bionostics, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K913133 · Bionostics, Inc. · Chemistry device
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Sep 1991
Decision
73d
Days
Class 1
Risk

K913133 is an FDA 510(k) clearance for the CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bionostics, Inc. (Acton, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Bionostics, Inc. devices

Submission Details

510(k) Number K913133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1991
Decision Date September 27, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 320
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K913133.
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K912441 · Boehringer Mannheim Corp. · Jul 1991