Cleared Traditional

K882538 - PROGENE MICROALBUMINURIA SCREEN

K882538 is the FDA 510(k) clearance for PROGENE MICROALBUMINURIA SCREEN by Progene Corp.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K882538 · Progene Corp. · Chemistry device
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Mar 1989
Decision
265d
Days
Class 1
Risk

K882538 is an FDA 510(k) clearance for the PROGENE MICROALBUMINURIA SCREEN. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Progene Corp. (Overland Park, US). The FDA issued a Cleared decision on March 13, 1989 after a review of 265 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 Progene Corp. devices

Submission Details

510(k) Number K882538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date March 13, 1989
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 88d · This submission: 265d
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 K882538.
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · Stanbio Laboratory · Aug 1990
BIOTEL MICROALBUMINURIA (TM)
K894169 · American Diagnostic Corp. · Sep 1989
BIOTROL URINE PROTEINS REAGENT
K890846 · Biotrol, USA, Inc. · Mar 1989
BIOTROL URINE PROTEINS REAGENT
K885053 · Biotrol, USA, Inc. · Jan 1989
MICRO-BUMINTEST REAGENT TABLETS
K874909 · Miles Laboratories, Inc. · Apr 1988
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338 · Diagnostic Products Corp. · Apr 1986