Cleared Traditional

K971935 - B&D ACTIVATED CLOTTING TIME (ACT) TEST ...

K971935 is the FDA 510(k) clearance for B&D ACTIVATED CLOTTING TIME (ACT) TEST ... by B & D Corp.. It is a Class 2 Hematology device (product code JBP) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K971935 · B & D Corp. · Hematology device
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Oct 1997
Decision
127d
Days
Class 2
Risk

K971935 is an FDA 510(k) clearance for the B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND.... Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by B & D Corp. (Metuchen, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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.

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Submission Details

510(k) Number K971935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date October 01, 1997
Days to Decision 127 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 113d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 - JBP Activated Whole Blood Clotting Time

All 8
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K971935.
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · Helena Laboratories · May 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · Helena Laboratories · Jan 2002
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp. · Jan 2000
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · International Technidyne Corp. · Aug 1996
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994
HEMOCHRON(R) KACT
K913861 · International Technidyne Corp. · Oct 1991