Cleared Traditional

K894169 - BIOTEL MICROALBUMINURIA (TM)

K894169 is the FDA 510(k) clearance for BIOTEL MICROALBUMINURIA (TM) by American Diagnostic Corp.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K894169 · American Diagnostic Corp. · Chemistry device
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Sep 1989
Decision
95d
Days
Class 1
Risk

K894169 is an FDA 510(k) clearance for the BIOTEL MICROALBUMINURIA (TM). Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by American Diagnostic Corp. (Oak Brook, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 95 days - within the typical 510(k) review window.

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 American Diagnostic Corp. devices

Submission Details

510(k) Number K894169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1989
Decision Date September 18, 1989
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
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 16
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K894169.
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · Boehringer Mannheim Corp. · Oct 1995
TINA-QUANT MICROALBUMIN
K932950 · Boehringer Mannheim Corp. · Feb 1995
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · Boehringer Mannheim Corp. · Apr 1991
MICRO-BUMINTEST REAGENT TABLETS
K874909 · Miles Laboratories, Inc. · Apr 1988
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338 · Diagnostic Products Corp. · Apr 1986
HELENA BIOSTRIP P
K830977 · Helena Laboratories · Apr 1983