Cleared Traditional

K103195 - I-STAT 1 WIRELESS ANALYZER

K103195 is an FDA 510(k) clearance for I-STAT 1 WIRELESS ANALYZER, 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 102-day FDA review.

K103195 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
102d
Days
Class 2
Risk

K103195 is an FDA 510(k) clearance for the I-STAT 1 WIRELESS ANALYZER. 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 8, 2011 after a review of 102 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 - K103195

510(k) Number K103195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2010
Decision Date February 08, 2011
Days to Decision 102 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
14d slower than avg
Panel avg: 88d · This submission: 102d
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 331
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