Cleared Traditional

STA-HYBRID HEP CALIBRATOR (K092937) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092937 · Diagnostica Stago, Inc. · Hematology device
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Aug 2010
Decision
312d
Days
Class 2
Risk

K092937 is an FDA 510(k) clearance for the STA-HYBRID HEP CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on August 2, 2010 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1150 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostica Stago, Inc. devices

Submission Details

510(k) Number K092937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date August 02, 2010
Days to Decision 312 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 113d · This submission: 312d
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 Hematology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 244
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