Cleared Traditional

K935062 - MAS LIQUID URINALYSIS CONTROL

K935062 is an FDA 510(k) clearance for MAS LIQUID URINALYSIS CONTROL, manufactured by Medical Analysis Systems, Inc.. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K935062 · Medical Analysis Systems, Inc. · Chemistry device
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Jan 1994
Decision
99d
Days
Class 1
Risk

K935062 is an FDA 510(k) clearance for the MAS LIQUID URINALYSIS CONTROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Analysis Systems, Inc. devices

FDA 510(k) Submission Details - K935062

510(k) Number K935062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date January 27, 1994
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 44
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K935062.
QUANTIFY(901)
K972710 · Hematronix, Inc. · Aug 1997
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
K943780 · Heraeus Kulzer, Inc. · Oct 1994
KOVA LIQUA-TROL
K942853 · Hycor Biomedical, Inc. · Oct 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