Cleared Dual Track

K220272 - cobas pulse blood glucose monitoring system (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K220272 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
816d
Days
Class 2
Risk

K220272 is an FDA 510(k) clearance for the cobas pulse blood glucose monitoring system. Classified as Prescription Use Blood Glucose Meter For Near-patient Testing (product code PZI), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 26, 2024 after a review of 816 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.

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Submission Details

510(k) Number K220272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2022
Decision Date April 26, 2024
Days to Decision 816 days
Submission Type Dual Track
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
728d slower than avg
Panel avg: 88d · This submission: 816d
Pathway characteristics

Device Classification

Product Code PZI Prescription Use Blood Glucose Meter For Near-patient Testing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
Definition Intended For Use In Near-patient Testing Settings For In Vitro Diagnostic, Multiple-patient Use For The Quantitative Determination Of Glucose Throughout All Hospital And All Professional Healthcare Settings For Use In Determining Dysglycemia.
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 - PZI Prescription Use Blood Glucose Meter For Near-patient Testing

All 12
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