Cleared Traditional

K980885 - SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

K980885 is an FDA 510(k) clearance for SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY, manufactured by Shield Diagnostics, Ltd.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K980885 · Shield Diagnostics, Ltd. · Hematology device
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Aug 1998
Decision
165d
Days
Class 2
Risk

K980885 is an FDA 510(k) clearance for the SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on August 21, 1998 after a review of 165 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shield Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K980885

510(k) Number K980885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date August 21, 1998
Days to Decision 165 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 113d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K980885.
VFE
K983107 · Ramco Laboratories, Inc. · Oct 1998
COAMATIC PLASMIN INHIBITOR
K981817 · Instrumentation Laboratory CO · Sep 1998
IL TEST PLASMIN INHIBITOR
K981696 · Instrumentation Laboratory CO · Aug 1998
IL TEST PLASMINOGEN
K981200 · Instrumentation Laboratory CO · May 1998
COAMATIC PLASMINOGEN
K974711 · Instrumentation Laboratory CO · May 1998
IL TEST PROTEIN C
K980875 · Instrumentation Laboratory CO · Apr 1998