Cleared Traditional

K013643 - AUSAM TOTAL ALBUMIN ASSAY

K013643 is an FDA 510(k) clearance for AUSAM TOTAL ALBUMIN ASSAY, manufactured by Ausam Biotecthnologies, Inc.. The device is a Class 1 Chemistry device with product code JIQ cleared through the Traditional 510(k) pathway after a 647-day FDA review.

K013643 · Ausam Biotecthnologies, Inc. · Chemistry device
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Aug 2003
Decision
647d
Days
Class 1
Risk

K013643 is an FDA 510(k) clearance for the AUSAM TOTAL ALBUMIN ASSAY. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Ausam Biotecthnologies, Inc. (New York, US). The FDA issued a Cleared decision on August 14, 2003 after a review of 647 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Ausam Biotecthnologies, Inc. devices

FDA 510(k) Submission Details - K013643

510(k) Number K013643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date August 14, 2003
Days to Decision 647 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
559d slower than avg
Panel avg: 88d · This submission: 647d
Pathway characteristics
Predicate-based equivalence.

JIQ Device Classification - Class 1, General Controls

Product Code JIQ Turbidimetric 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 - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 12
Devices cleared under the same product code (JIQ) and FDA review panel - the closest regulatory comparables to K013643.
TOTAL PROTEIN URINE/CSF GEN.3
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K971458 · Diagnostic Specialties · Sep 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
K965035 · Beckman Instruments, Inc. · Apr 1997
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
K944664 · Wako Chemicals USA, Inc. · Feb 1995
URINARY ALBUMIN TEST PACK
K936202 · Dupont Medical Products · May 1994