Cleared Traditional

K960274 - ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY

K960274 is an FDA 510(k) clearance for ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY, manufactured by Orgentec. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K960274 · Orgentec · Chemistry device
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Mar 1996
Decision
70d
Days
Class 1
Risk

K960274 is an FDA 510(k) clearance for the ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Orgentec (Windham, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 70 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 Orgentec devices

FDA 510(k) Submission Details - K960274

510(k) Number K960274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1996
Decision Date March 29, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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 29
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K960274.
ORGENTEC MICRO-ALBUMIN EIA ASSAY
K970932 · American Laboratory Products Co., Ltd. · Apr 1997
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142 · Bayer Corp. · Sep 1996
TOTAL PROTEIN (URINE)
K951222 · Randox Laboratories, Ltd. · Apr 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
K955438 · Teco Diagnostics · Jan 1996
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · Boehringer Mannheim Corp. · Oct 1995
TINA-QUANT MICROALBUMIN
K932950 · Boehringer Mannheim Corp. · Feb 1995