Cleared Traditional

K992851 - ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM

K992851 is an FDA 510(k) clearance for ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K992851 · Roche Diagnostics Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
143d
Days
Class 2
Risk

K992851 is an FDA 510(k) clearance for the ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO S.... Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 14, 2000 after a review of 143 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.

FDA 510(k) Submission Details - K992851

510(k) Number K992851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1999
Decision Date January 14, 2000
Days to Decision 143 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 113d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBP Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K992851.
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
K002528 · Sienco, Inc. · Aug 2000
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194 · Cardiovascular Diagnostics, Inc. · Mar 2000
I-STAT SYSTEM
K992571 · I-Stat Corp. · Feb 2000
GBACT + KIT
K984141 · Sienco, Inc. · May 1999
MAX-ACT
K983649 · Array Medical, Inc. · Dec 1998
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
K971935 · B & D Corp. · Oct 1997
K992851 · ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
Download PDF FDA Summary Roche Diagnostics Cor…