Cleared Traditional

K022085 - J&S MEDICAL SENTRY URINE DIPSTICK CONTROL

K022085 is an FDA 510(k) clearance for J&S MEDICAL SENTRY URINE DIPSTICK CONTROL, manufactured by J & S Medical Assoc., Inc.. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K022085 · J & S Medical Assoc., Inc. · Chemistry device
Download Printable Device Report (PDF)
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Jul 2002
Decision
28d
Days
Class 1
Risk

K022085 is an FDA 510(k) clearance for the J&S MEDICAL SENTRY URINE DIPSTICK CONTROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by J & S Medical Assoc., Inc. (Framingham, US). The FDA issued a Cleared decision on July 25, 2002 after a review of 28 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 J & S Medical Assoc., Inc. devices

FDA 510(k) Submission Details - K022085

510(k) Number K022085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2002
Decision Date July 25, 2002
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 45
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K022085.
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · Medical Analysis Systems, Inc. · Jul 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
K031231 · Bio-Rad · Jun 2003
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
K023928 · Medical Analysis Systems, Inc. · Dec 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · Medical Analysis Systems, Inc. · Apr 2002
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · Bio-Rad · Apr 2000
URINE CHEMISTRY CONTROL, LEVEL 1
K992576 · Consolidated Technologies, Inc. · Sep 1999