Cleared Traditional

K121027 - DIAMOND CALIBRATOR LOW

K121027 is the FDA 510(k) clearance for DIAMOND CALIBRATOR LOW by Diamond Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K121027 · Diamond Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
260d
Days
Class 2
Risk

K121027 is an FDA 510(k) clearance for the DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH. 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 December 20, 2012 after a review of 260 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 K121027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date December 20, 2012
Days to Decision 260 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
172d slower than avg
Panel avg: 88d · This submission: 260d
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
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K121027.
Elecsys Estradiol III CalSet
K142021 · Roche Diagnostics · Aug 2014
CA 125 II CALSET II
K140112 · Roche Diagnostics · Jun 2014
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · Siemens Healthcare Diagnostics · Apr 2013
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · Siemens Healthcare Diagnostics, Inc. · Dec 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K111952 · Beckman Coulter, Inc. · Aug 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · Abbott Laboratories · Jun 2011