Cleared Traditional

K020596 - CALIBRATING MATERIAL

K020596 is an FDA 510(k) clearance for CALIBRATING MATERIAL, manufactured by Diamond Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K020596 · Diamond Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
29d
Days
Class 2
Risk

K020596 is an FDA 510(k) clearance for the CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS. 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 March 23, 2002 after a review of 29 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 Diamond Diagnostics, Inc. devices

FDA 510(k) Submission Details - K020596

510(k) Number K020596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2002
Decision Date March 23, 2002
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 184
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K020596.
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
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K020980 · Dade Behring, Inc. · Jun 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · Dade Behring, Inc. · May 2002
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850 · Diamond Diagnostics, Inc. · Dec 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · Beckman Coulter, Inc. · Oct 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · Nichols Institute Diagnostics · Oct 2001