Cleared Traditional

K093357 - DIAMOND MEDICA ISE MODULE CALIBRANT A M...

K093357 is the FDA 510(k) clearance for DIAMOND MEDICA ISE MODULE CALIBRANT A M... by Diamond Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K093357 · Diamond Diagnostics, Inc. · Chemistry device
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Jun 2010
Decision
239d
Days
Class 2
Risk

K093357 is an FDA 510(k) clearance for the DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODU.... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 239 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Diamond Diagnostics, Inc. devices

Submission Details

510(k) Number K093357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2009
Decision Date June 24, 2010
Days to Decision 239 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 88d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 142
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