Cleared Abbreviated

K000783 - DIRECT TIBC CALIBRATOR

K000783 is an FDA 510(k) clearance for DIRECT TIBC CALIBRATOR, manufactured by Reference Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Abbreviated 510(k) pathway after a 55-day FDA review.

K000783 · Reference Diagnostics, Inc. · Chemistry device
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May 2000
Decision
55d
Days
Class 2
Risk

K000783 is an FDA 510(k) clearance for the DIRECT TIBC CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on May 4, 2000 after a review of 55 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Reference Diagnostics, Inc. devices

FDA 510(k) Submission Details - K000783

510(k) Number K000783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2000
Decision Date May 04, 2000
Days to Decision 55 days
Submission Type Abbreviated
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
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Standards-based clearance path.

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 206
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K000783.
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
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ACCESS ULTRASENSITIVE HGH CALIBRATORS
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DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc. · Mar 2000
GENZYME DIRECT AMYLASE VERIFIER
K993132 · Genzyme Corp. · Oct 1999
ELECSYS ESTRADIOL CALSET II
K992981 · Roche Diagnostics Corp. · Sep 1999