Cleared Traditional

K992571 - I-STAT SYSTEM

K992571 is an FDA 510(k) clearance for I-STAT SYSTEM, manufactured by I-Stat Corp.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K992571 · I-Stat Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
192d
Days
Class 2
Risk

K992571 is an FDA 510(k) clearance for the I-STAT SYSTEM. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 192 days - an extended review cycle.

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.

View all I-Stat Corp. devices

FDA 510(k) Submission Details - K992571

510(k) Number K992571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date February 10, 2000
Days to Decision 192 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
79d slower than avg
Panel avg: 113d · This submission: 192d
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 14
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K992571.
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
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194 · Cardiovascular Diagnostics, Inc. · Mar 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp. · Jan 2000
GBACT + KIT
K984141 · Sienco, Inc. · May 1999
MAX-ACT
K983649 · Array Medical, Inc. · Dec 1998