Cleared Traditional

K832713 - IRI SPEC URINALYSIS CONTROL

K832713 is an FDA 510(k) clearance for IRI SPEC URINALYSIS CONTROL, manufactured by Intl. Remote Imaging Systems. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K832713 · Intl. Remote Imaging Systems · Chemistry device
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Dec 1983
Decision
132d
Days
Class 1
Risk

K832713 is an FDA 510(k) clearance for the IRI SPEC URINALYSIS CONTROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Intl. Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 132 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 Intl. Remote Imaging Systems devices

FDA 510(k) Submission Details - K832713

510(k) Number K832713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date December 22, 1983
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 K832713.
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565 · Icl Scientific · Oct 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366 · Sigma Chemical Co. · Sep 1984
BIOSURE
K840848 · Helena Laboratories · May 1984
URINE TOTAL PROTEIN CONTROL
K831526 · Quantimetrix Corp. · Aug 1983
BIOCHECK POSITIVE URINE CONTROL
K831994 · Helena Laboratories · Aug 1983
NEGATIVE URINE CONTROL
K830834 · Helena Laboratories · Apr 1983