Cleared Traditional

K982639 - SPIFE URINE IFE

K982639 is an FDA 510(k) clearance for SPIFE URINE IFE, manufactured by Helena Laboratories. The device is a Class 2 Immunology device with product code DAO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K982639 · Helena Laboratories · Immunology device
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Nov 1998
Decision
98d
Days
Class 2
Risk

K982639 is an FDA 510(k) clearance for the SPIFE URINE IFE. Classified as Igm (mu Chain Specific), Antigen, Antiserum, Control (product code DAO), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K982639

510(k) Number K982639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1998
Decision Date November 04, 1998
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 105d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAO Device Classification - Class 2, Special Controls

Product Code DAO Igm (mu Chain Specific), Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DAO Igm (mu Chain Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DAO) and FDA review panel - the closest regulatory comparables to K982639.
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · Roche Diagnostics Corp. · Mar 2004
BOEHRINGER MANNHEIM IGM ASSAY
K955908 · Boehringer Mannheim Corp. · Feb 1996
MODIFICATION TO ACS CORONARY GUIDING
K841992 · Advanced Cardiovascular Systems, Inc. · Jun 1984
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
K812487 · Dako Corp. · Sep 1981
GEMENI IGM ASSAY
K800450 · Electro-Nucleonics Laboratories, Inc. · Apr 1980
ANTISERUM TO HUMAN IGM
K790705 · Kent Laboratories, Inc. · Apr 1979