Cleared Traditional

K191298 - i-STAT CHEM8+ cartridge with the i-STAT...

K191298 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 JFL cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K191298 · 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

K191298 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on February 7, 2020 after a review of 269 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 - K191298

510(k) Number K191298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date February 07, 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.

JFL Device Classification - Class 2, Special Controls

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - JFL Ph Rate Measurement, Carbon-dioxide

All 21
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K191298.
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034 · Beckman Coulter, Inc. · Dec 2001
SIGMA DIAGNOSTICS CO2 ACID REAGENT
K963541 · Sigma Diagnostics, Inc. · Oct 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
K963538 · Sigma Diagnostics, Inc. · Oct 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
K963540 · Sigma Diagnostics, Inc. · Sep 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005 · Nova Biomedical Corp. · Aug 1996
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · Sigma Chemical Co. · Jan 1994