Cleared Traditional

K910636 - ABS CADKIT

K910636 is an FDA 510(k) clearance for ABS CADKIT, manufactured by Panbio, Inc.. The device is a Class 2 Hematology device with product code GIS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K910636 · Panbio, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
75d
Days
Class 2
Risk

K910636 is an FDA 510(k) clearance for the ABS CADKIT. Classified as Test, Fibrinogen (product code GIS), Class II - Special Controls.

Submitted by Panbio, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Panbio, Inc. devices

FDA 510(k) Submission Details - K910636

510(k) Number K910636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1991
Decision Date April 29, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 113d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIS Device Classification - Class 2, Special Controls

Product Code GIS Test, Fibrinogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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 - GIS Test, Fibrinogen

All 10
Devices cleared under the same product code (GIS) and FDA review panel - the closest regulatory comparables to K910636.
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494 · Biomerieux Vitek, Inc. · May 1993
IL TEST PT FIBRINOGEN HS
K923921 · Instrumentation Laboratory CO · Oct 1992
FIBRINOGEN DETERMINATION KIT
K913061 · Sigma Diagnostics, Inc. · Oct 1991
FIBRINOGENTEST-O
K881685 · Diatech, Inc. · Aug 1988
KINETIC FIBRINOGEN ASSAY
K881150 · Bio/Data Corp. · Mar 1988
ASSAY KIT, THROMBO-SCREEN
K781880 · Pacific Hemostasis · Dec 1978