Cleared Traditional

K013850 - STANDARD A

K013850 is the FDA 510(k) clearance for STANDARD A by Diamond Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K013850 · Diamond Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
31d
Days
Class 2
Risk

K013850 is an FDA 510(k) clearance for the STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE. 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 21, 2001 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 Diamond Diagnostics, Inc. devices

Submission Details

510(k) Number K013850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2001
Decision Date December 21, 2001
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.

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 K013850.
ELECSYS LH CALSET II
K031299 · Roche Diagnostics Corp. · May 2003
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · Dade Behring, Inc. · Jun 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · Dade Behring, Inc. · May 2002
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
STRATUS CS TROPONIN I CALIBRATOR
K012233 · Dade Behring, Inc. · Sep 2001