Cleared Special

K031299 - ELECSYS LH CALSET II

K031299 is an FDA 510(k) clearance for ELECSYS LH CALSET II, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JIT cleared through the Special 510(k) pathway after a 18-day FDA review.

K031299 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
18d
Days
Class 2
Risk

K031299 is an FDA 510(k) clearance for the ELECSYS LH CALSET II. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 12, 2003 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031299

510(k) Number K031299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date May 12, 2003
Days to Decision 18 days
Submission Type Special
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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 225
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K031299.
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K031299 · ELECSYS LH CALSET II
Download PDF FDA Summary Roche Diagnostics Cor…