Cleared Traditional

K951640 - HUMAN PROTEIN S RID TEST KIT

K951640 is an FDA 510(k) clearance for HUMAN PROTEIN S RID TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 742-day FDA review.

K951640 · The Binding Site, Ltd. · Hematology device
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Apr 1997
Decision
742d
Days
Class 2
Risk

K951640 is an FDA 510(k) clearance for the HUMAN PROTEIN S RID TEST KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 742 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Hematology submissions.

View all The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K951640

510(k) Number K951640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date April 21, 1997
Days to Decision 742 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
629d slower than avg
Panel avg: 113d · This submission: 742d
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 K951640.
REAADS PROTEIN S ANTIGEN TEST KIT
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VON WILLEBRAND REAGENT
K972116 · Behring Diagnostics, Inc. · Jul 1997
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
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UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270 · Universal Reagents, Inc. · Dec 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459 · Universal Reagents, Inc. · Dec 1996
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · Behring Diagnostics, Inc. · Dec 1996