Cleared Traditional

K001907 - CAMIT DIABETES MANAGEMENT SOFTWARE

K001907 is the FDA 510(k) clearance for CAMIT DIABETES MANAGEMENT SOFTWARE by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K001907 · Roche Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
75d
Days
Class 2
Risk

K001907 is an FDA 510(k) clearance for the CAMIT DIABETES MANAGEMENT SOFTWARE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 5, 2000 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K001907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2000
Decision Date September 05, 2000
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
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 127
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K001907.
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RANDOX GLUCOSE (GOD/PAP)
K003346 · Randox Laboratories, Ltd. · Mar 2001
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp. · Feb 2000
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
K990649 · Bayer Corp. · Jul 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · Bayer Corp. · Jun 1999