Cleared Traditional

K092937 - STA-HYBRID HEP CALIBRATOR

K092937 is an FDA 510(k) clearance for STA-HYBRID HEP CALIBRATOR, manufactured by Diagnostica Stago, Inc.. The device is a Class 2 Hematology device with product code JIT cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K092937 · Diagnostica Stago, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K092937

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
Combination Product No
PCCP Authorized No
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.

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 Hematology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 215
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K092937.
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
K103221 · Roche Diagnostics · Dec 2010
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
K103360 · Siemens Corp. · Dec 2010
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
K102638 · Diazyme Laboratories · Nov 2010
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
K093357 · Diamond Diagnostics, Inc. · Jun 2010
ABX PENTRA TPU CAL, MODEL A11A01898
K092570 · HORIBA ABX SAS · Oct 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462 · Siemens Healthcare Diagnostics · Feb 2009