Cleared Traditional

K022027 - CALIBRATING MATERIAL, BUFFERS, STANDARD

K022027 is an FDA 510(k) clearance for CALIBRATING MATERIAL, manufactured by Mission Diagnostics. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K022027 · Mission Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
31d
Days
Class 2
Risk

K022027 is an FDA 510(k) clearance for the CALIBRATING MATERIAL, BUFFERS, STANDARD. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Mission Diagnostics (Holliston, US). The FDA issued a Cleared decision on July 22, 2002 after a review of 31 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 Mission Diagnostics devices

FDA 510(k) Submission Details - K022027

510(k) Number K022027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2002
Decision Date July 22, 2002
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 213
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K022027.
CALIBRATING MATERIAL, CALIBRATING STANDARDS
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K021532 · Bayer Diagnostics Corp. · Jun 2002
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K021535 · Bayer Diagnostics Corp. · Jun 2002
RDI HS CRP CALIBRATOR SET
K021607 · Reference Diagnostics, Inc. · Jun 2002