Cleared Traditional

K991315 - MICROALBUSTIX REAGENT STRIPS (OTC)

K991315 is an FDA 510(k) clearance for MICROALBUSTIX REAGENT STRIPS (OTC), manufactured by Bayer Corp.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K991315

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.

JIR Device Classification - Class 1, General Controls

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 30
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
HEALTH CHECK URI-TEST PROTEIN IN URINE
K972960 · Tcpi, Inc. · Oct 1998
MICROALBUSTIX REAGENT STRIPS
K982219 · Bayer Corp. · Aug 1998