Cleared Traditional

K943630 - DIASTAT ANTI-MPO (PANCA) KIT

K943630 is an FDA 510(k) clearance for DIASTAT ANTI-MPO (PANCA) KIT, manufactured by Shield Diagnostics, Ltd.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K943630 · Shield Diagnostics, Ltd. · Immunology device
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Mar 1995
Decision
223d
Days
Class 2
Risk

K943630 is an FDA 510(k) clearance for the DIASTAT ANTI-MPO (PANCA) KIT. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on March 6, 1995 after a review of 223 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 Shield Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K943630

510(k) Number K943630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date March 06, 1995
Days to Decision 223 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 105d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
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.