Cleared Traditional

K971464 - IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

K971464 is an FDA 510(k) clearance for IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT, manufactured by Euro-Diagnostica AB. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K971464 · Euro-Diagnostica AB · Immunology device
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Oct 1997
Decision
190d
Days
Class 2
Risk

K971464 is an FDA 510(k) clearance for the IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Euro-Diagnostica AB (Ringoes, US). The FDA issued a Cleared decision on October 29, 1997 after a review of 190 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Euro-Diagnostica AB devices

FDA 510(k) Submission Details - K971464

510(k) Number K971464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1997
Decision Date October 29, 1997
Days to Decision 190 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
85d slower than avg
Panel avg: 105d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBL Device Classification - Class 2, Special Controls

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 17
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K971464.
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