ST AIA-Pack C-Peptide II Calibrator Set
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- AIA-PACK C-Peptide II Calibrator Set FDA UDI
- Generic Name
- C-peptide IVD, calibrator FDA UDI
- Device Name
- ST AIA-PACK C-PeptideII CALIBRATOR SET EUDAMED
- Model / Reference
- 0025383 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189213333 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189213333 EUDAMED
- 510(k) Number
- K140648 FDA 510(k)
- FDA Product Code
- JIT FDA 510(k)FDA UDI
- EMDN Code
- W0102060101 C-PEPTIDE EUDAMED
- GMDN Term
- C-peptide IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The ST AIA-Pack C-Peptide II Calibrator Set is a secondary calibrator designed for use in immunoassay systems. It provides standardized reference materials for quantifying C-peptide levels, a biomarker used to assess insulin production in clinical chemistry testing.
This set is intended for in vitro diagnostic use in clinical laboratories, supplied as a non-sterile, single-use reagent. It is regulated under the FDA’s 510(k) pathway and the In Vitro Diagnostic Device Directive (IVDD), with a classification as a Class II device. Storage and handling follow standard laboratory protocols for immunoassay calibrators, ensuring accuracy and traceability in diagnostic measurements.
Frequently asked questions
What is the primary purpose of the ST AIA-Pack C-Peptide II Calibrator Set in clinical testing?
The ST AIA-Pack C-Peptide II Calibrator Set is designed to provide standardized reference materials for immunoassay systems, enabling accurate quantification of C-peptide levels in clinical chemistry testing. C-peptide is a biomarker used to assess insulin production, making this calibrator essential for reliable diagnostic measurements in clinical laboratories.
Is this calibrator set intended for single-use or repeated use in a laboratory?
The ST AIA-Pack C-Peptide II Calibrator Set is explicitly labeled as a single-use reagent, meaning each set is intended for one-time use in immunoassay systems. This ensures accuracy and prevents cross-contamination, adhering to standard laboratory protocols for calibrators.
How should the ST AIA-Pack C-Peptide II Calibrator Set be stored, and is it sterile?
The set is supplied as non-sterile, so it does not require sterile storage conditions. However, it should be stored and handled according to standard laboratory protocols for immunoassay calibrators to maintain accuracy and traceability. This typically involves refrigeration (unless otherwise specified by the manufacturer) and protection from light or extreme temperatures.
What regulatory pathways does this calibrator set follow, and what does that mean for its use?
The ST AIA-Pack C-Peptide II Calibrator Set is regulated under the FDA’s 510(k) pathway and the In Vitro Diagnostic Device Directive (IVDD), classified as a Class II device. This means it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring its safety and performance for in vitro diagnostic use in clinical laboratories.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140648 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (3)
- FDA 510(k) K140648 24 fields · synced Sep 18, 2026
- FDA UDI 77bccac5-b12d-4d0d-a3a2-3914e879748e 34 fields · synced May 30, 2026
- EUDAMED 81f013b3-ccfe-494b-abcf-54bba627e6af 61 fields · synced Jul 21, 2026