Cleared Traditional

K994035 - IMMUNODIP URINARY ALBUMIN SCREEN

K994035 is the FDA 510(k) clearance for IMMUNODIP URINARY ALBUMIN SCREEN by Diagnostic Chemicals , Ltd.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K994035 · Diagnostic Chemicals , Ltd. · Chemistry device
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Feb 2000
Decision
64d
Days
Class 1
Risk

K994035 is an FDA 510(k) clearance for the IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on February 1, 2000 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K994035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1999
Decision Date February 01, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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 - JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)

All 25
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K994035.
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330 · ACON Laboratories, Inc. · Apr 2015
TECO MICROALBUMIN 2-1 COMBO STRIPS
K061419 · Teco Diagnostics · Jan 2007
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · Diagnostic Chemicals, Ltd. (Usa) · Aug 2002
NEW MULTIPLES REAGENT STRIPS
K992257 · Bayer Corp. · Nov 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
K991315 · Bayer Corp. · Nov 1999
UALB
K983774 · Abbott Laboratories · Jan 1999