Cleared Traditional

K000471 - FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

K000471 is an FDA 510(k) clearance for FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERA..., manufactured by Future Diagnostics B.V.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K000471 · Future Diagnostics B.V. · Chemistry device
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Apr 2000
Decision
57d
Days
Class 2
Risk

K000471 is an FDA 510(k) clearance for the FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Future Diagnostics B.V. (San Diego, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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 Future Diagnostics B.V. devices

FDA 510(k) Submission Details - K000471

510(k) Number K000471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2000
Decision Date April 11, 2000
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 75
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K000471.
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K992680 · Roche Diagnostics Corp. · Sep 1999
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K992105 · Diagnostic Products Corp. · Jul 1999
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K974306 · Sangui Biotech, Inc. · Dec 1997