Cleared Traditional

i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183678) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183678 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
406d
Days
Class 2
Risk

K183678 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 February 7, 2020 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abbott Point of Care, Inc. devices

Submission Details

510(k) Number K183678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2018
Decision Date February 07, 2020
Days to Decision 406 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
318d slower than avg
Panel avg: 88d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K183678.
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K182781 · Polymer Technology Systems, Inc. D/B/A Pts Diagnostics · Dec 2018