Cleared Traditional

K001810 - URISITE URINE COLLECTION KIT FOR MICROA...

K001810 is the FDA 510(k) clearance for URISITE URINE COLLECTION KIT FOR MICROA... by Flexsite Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K001810 · Flexsite Diagnostics, Inc. · Chemistry device
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Aug 2000
Decision
60d
Days
Class 1
Risk

K001810 is an FDA 510(k) clearance for the URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Flexsite Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on August 14, 2000 after a review of 60 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 Flexsite Diagnostics, Inc. devices

Submission Details

510(k) Number K001810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2000
Decision Date August 14, 2000
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
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 26
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K001810.
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
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · Diagnostic Chemicals , Ltd. · Feb 2000
NEW MULTIPLES REAGENT STRIPS
K992257 · Bayer Corp. · Nov 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
K991315 · Bayer Corp. · Nov 1999