Cleared Traditional

DRI-DYE CHECK STRIPS (TM)-405 (K892656) - FDA 510(k) Clearance

Class I Chemistry device.

K892656 · Awareness Technology, Inc. · Chemistry device
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May 1989
Decision
39d
Days
Class 1
Risk

K892656 is an FDA 510(k) clearance for the DRI-DYE CHECK STRIPS (TM)-405. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on May 22, 1989 after a review of 39 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 Awareness Technology, Inc. devices

Submission Details

510(k) Number K892656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date May 22, 1989
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 245
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K892656.
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RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
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LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475 · Bio-Rad · Aug 1989
QTEST PREGNANCY TEST CONTROL
K883741 · Quidel Corp. · Oct 1988
QUIDEL PREGNANCY TEST CONTROL
K883316 · Quidel Corp. · Sep 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · Sigma Diagnostics, Inc. · Feb 1988