Cleared Traditional

K913670 - HAPTOGLOBIN IMMUNOLOGICAL TEST KIT

K913670 is an FDA 510(k) clearance for HAPTOGLOBIN IMMUNOLOGICAL TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code DAB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K913670 · The Binding Site, Ltd. · Immunology device
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Dec 1991
Decision
112d
Days
Class 2
Risk

K913670 is an FDA 510(k) clearance for the HAPTOGLOBIN IMMUNOLOGICAL TEST KIT. Classified as Haptoglobin, Fitc, Antigen, Antiserum, Control (product code DAB), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5460 - 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 The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K913670

510(k) Number K913670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date December 09, 1991
Days to Decision 112 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 slower than avg
Panel avg: 105d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAB Device Classification - Class 2, Special Controls

Product Code DAB Haptoglobin, Fitc, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5460
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.