Cleared Traditional

K951585 - T-UPTAKE CALIBRATORS

K951585 is the FDA 510(k) clearance for T-UPTAKE CALIBRATORS by Diagnostic Reagents, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K951585 · Diagnostic Reagents, Inc. · Chemistry device
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Jun 1995
Decision
70d
Days
Class 2
Risk

K951585 is an FDA 510(k) clearance for the T-UPTAKE CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 15, 1995 after a review of 70 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K951585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1995
Decision Date June 15, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K951585.
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WAKO DIRECT HDL-C
K963847 · Wako Chemicals USA, Inc. · Dec 1996
SYNCHRON ENZYME VALIDATOR SET
K951964 · Beckman Instruments, Inc. · Jun 1995
IMX ESTRADIOL
K951629 · Abbott Laboratories · May 1995
CALIBRATORS
K944701 · Diagnostic Reagents, Inc. · Nov 1994
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · King Diagnostics, Inc. · Aug 1993