Cleared Traditional

K991315 - MICROALBUSTIX REAGENT STRIPS (OTC)

K991315 is the FDA 510(k) clearance for MICROALBUSTIX REAGENT STRIPS (OTC) by Bayer Corp.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K991315 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
207d
Days
Class 1
Risk

K991315 is an FDA 510(k) clearance for the MICROALBUSTIX REAGENT STRIPS (OTC). Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on November 12, 1999 after a review of 207 days - an extended review 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: 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 Bayer Corp. devices

Submission Details

510(k) Number K991315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date November 12, 1999
Days to Decision 207 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
119d slower than avg
Panel avg: 88d · This submission: 207d
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 K991315.
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
UALB
K983774 · Abbott Laboratories · Jan 1999
MICROALBUSTIX REAGENT STRIPS
K982219 · Bayer Corp. · Aug 1998
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
K972337 · Diagnostic Chemicals , Ltd. · Aug 1997