Cleared Traditional

K902699 - SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)

K902699 is an FDA 510(k) clearance for SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED..., manufactured by Actio, Inc.. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K902699 · Actio, Inc. · Chemistry device
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Jul 1990
Decision
27d
Days
Class 1
Risk

K902699 is an FDA 510(k) clearance for the SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY). Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Actio, Inc. (Oakland, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 27 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 Actio, Inc. devices

FDA 510(k) Submission Details - K902699

510(k) Number K902699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date July 16, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JJW Device Classification - Class 1, General Controls

Product Code JJW Urinalysis 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 - JJW Urinalysis Controls (assayed And Unassayed)

All 47
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K902699.
KOVA LIQUA-TROL
K942853 · Hycor Biomedical, Inc. · Oct 1994
MAS LIQUID URINALYSIS CONTROL
K935062 · Medical Analysis Systems, Inc. · Jan 1994
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467 · Heraeus Kulzer, Inc. · May 1993
BIOTROL CHEMISTRY URINE CONTROL
K891286 · Biotrol, USA, Inc. · Apr 1989
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
K890534 · Fisher Scientific Co., LLC · Mar 1989
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · Bio-Rad · Dec 1988