Cleared Traditional

K982219 - MICROALBUSTIX REAGENT STRIPS

K982219 is the FDA 510(k) clearance for MICROALBUSTIX REAGENT STRIPS by Bayer Corp.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K982219 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
49d
Days
Class 1
Risk

K982219 is an FDA 510(k) clearance for the MICROALBUSTIX REAGENT STRIPS. 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 August 12, 1998 after a review of 49 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 Bayer Corp. devices

Submission Details

510(k) Number K982219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1998
Decision Date August 12, 1998
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 K982219.
NEW MULTIPLES REAGENT STRIPS
K992257 · Bayer Corp. · Nov 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
K991315 · Bayer Corp. · Nov 1999
UALB
K983774 · Abbott Laboratories · Jan 1999
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
K972337 · Diagnostic Chemicals , Ltd. · Aug 1997
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142 · Bayer Corp. · Sep 1996
TOTAL PROTEIN (URINE)
K951222 · Randox Laboratories, Ltd. · Apr 1996