Cleared Traditional

K191360 - i-STAT CHEM8+ cartridge with the i-STAT...

K191360 is an FDA 510(k) clearance for i-STAT CHEM8+ cartridge with the i-STAT..., manufactured by Abbott Point of Care, Inc.. The device is a Class 2 Chemistry device with product code JFP cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K191360 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
269d
Days
Class 2
Risk

K191360 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on February 14, 2020 after a review of 269 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Point of Care, Inc. devices

FDA 510(k) Submission Details - K191360

510(k) Number K191360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2019
Decision Date February 14, 2020
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 88d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFP Device Classification - Class 2, Special Controls

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 Chemistry devices follow this clearance model.

Regulatory Peers - JFP Electrode, Ion Specific, Calcium

All 16
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