Cleared Traditional

K081789 - DIMENSION CLINICAL CHEMISTRY SYSTEM ENZ...

K081789 is an FDA 510(k) clearance for DIMENSION CLINICAL CHEMISTRY SYSTEM ENZ..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K081789 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
77d
Days
Class 2
Risk

K081789 is an FDA 510(k) clearance for the DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on September 10, 2008 after a review of 77 days - a notably fast clearance 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: 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K081789

510(k) Number K081789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2008
Decision Date September 10, 2008
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

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 186
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