Cleared Traditional

K210958 - i-STAT CHEM8+ cartridge with the i-STAT...

K210958 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 CGA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K210958 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
135d
Days
Class 2
Risk

K210958 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on August 13, 2021 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 - K210958

510(k) Number K210958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2021
Decision Date August 13, 2021
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 223
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