Cleared Traditional

K162042 - OptiScanner 5000 Glucose Monitoring System

K162042 is an FDA 510(k) clearance for OptiScanner 5000 Glucose Monitoring System, manufactured by Optiscan Biomedical Corp.. The device is a Class 2 Chemistry device with product code LZF cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K162042 · Optiscan Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
448d
Days
Class 2
Risk

K162042 is an FDA 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System. Classified as Pump, Infusion, Analytical Sampling (product code LZF), Class II - Special Controls.

Submitted by Optiscan Biomedical Corp. (Hayward, US). The FDA issued a Cleared decision on October 16, 2017 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5725 - 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 Optiscan Biomedical Corp. devices

FDA 510(k) Submission Details - K162042

510(k) Number K162042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date October 16, 2017
Days to Decision 448 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
360d slower than avg
Panel avg: 88d · This submission: 448d
Pathway characteristics
Predicate-based equivalence.

LZF Device Classification - Class 2, Special Controls

Product Code LZF Pump, Infusion, Analytical Sampling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02211300 Unknown Interventional Industry-sponsored

MANAGE Automated Glucose Monitoring

MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE

230
Patients (est.)
4
Sites
Supportive_care
Purpose
Double blind
Masking
Condition studied ICU/CCU Patients Requiring Blood Glucose Monitoring
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Grant V Bochicchio, MD, MPH
Sponsor OptiScan Biomedical Corporation (industry)
Started 2014-04-01 → Primary completion 2015-09-01 → Completed 2015-12-01
Primary outcome
Primary Accuracy Endpoint
Secondary outcome
Secondary Accuracy Endpoint
View full study on ClinicalTrials.gov