Cleared Traditional

K945913 - IRISPEC URINE CHEMISTRY CONTROL PART A AND B

K945913 is an FDA 510(k) clearance for IRISPEC URINE CHEMISTRY CONTROL PART A ..., manufactured by International Remote Imaging Systems. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K945913 · International Remote Imaging Systems · Chemistry device
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Apr 1995
Decision
124d
Days
Class 1
Risk

K945913 is an FDA 510(k) clearance for the IRISPEC URINE CHEMISTRY CONTROL PART A AND B. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by International Remote Imaging Systems (Chartsworth, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 124 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 International Remote Imaging Systems devices

FDA 510(k) Submission Details - K945913

510(k) Number K945913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date April 05, 1995
Days to Decision 124 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
36d slower than avg
Panel avg: 88d · This submission: 124d
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 K945913.
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
K981933 · Medical Analysis Systems, Inc. · Jun 1998
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451 · Medical Analysis Systems, Inc. · Sep 1997
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
MAS LIQUID URINALYSIS CONTROL
K935062 · Medical Analysis Systems, Inc. · Jan 1994