St Aia-Pack Acth, And St Aia-Pack Acth Calibrator Set Model 025221 And 025321
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ST AIA-PACK ACTH Calibrator Set FDA UDI
- Generic Name
- Adrenocorticotropic hormone (ACTH) IVD, calibrator FDA UDI
- Device Name
- ST AIA-PACK ACTH CALIBRATOR SET EUDAMED
- Model / Reference
- 0025321 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189212534 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189212534 EUDAMED
- 510(k) Number
- K111335 FDA 510(k)
- FDA Product Code
- CKG FDA 510(k)JIT FDA UDI
- EMDN Code
- W0102060401 ADRENOCORTICOTROPIC HORMONE EUDAMED
- GMDN Term
- Adrenocorticotropic hormone (ACTH) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 862.1025 FDA 510(k)
- Regulation Number
- 862.1025 FDA 510(k)862.1150 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The ST AIA-PACK ACTH is a radioimmunoassay for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. It is designed for use on TOSOH AIA systems, providing precise detection of ACTH levels to support clinical chemistry diagnostics.
This device is supplied as a single-use in-vitro diagnostic reagent, intended for laboratory use only. The ST AIA-PACK ACTH Calibrator Set (Models 025221 and 025321) is used for calibration, while the control set ensures assay accuracy. Both components comply with FDA 510(k) clearance and IVDD regulations, ensuring adherence to clinical chemistry standards.
Frequently asked questions
What clinical chemistry applications is the ST AIA-PACK ACTH designed for, and how does it support diagnostic testing?
The ST AIA-PACK ACTH is a radioimmunoassay specifically designed for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. It is intended for use in clinical chemistry laboratories to provide precise detection of ACTH levels, aiding in the diagnosis and monitoring of conditions related to adrenal function, such as Cushing’s syndrome or Addison’s disease. The assay is compatible with TOSOH AIA systems, ensuring reliable results for clinical decision-making.
Are the ST AIA-PACK ACTH reagents single-use, and how should they be stored to maintain integrity?
Yes, the ST AIA-PACK ACTH is supplied as a single-use in-vitro diagnostic reagent, meaning each package is intended for one assay cycle only. To preserve sterility and performance, it should be stored in a cool, dry place, protected from direct light, and refrigerated (typically between 2°C and 8°C) until use. Avoid freezing, as this may compromise the reagent’s stability and accuracy.
What are the key components of the ST AIA-PACK ACTH Calibrator Set (Models 025221 and 025321), and how do they contribute to assay accuracy?
The ST AIA-PACK ACTH Calibrator Set includes standardized reference materials used to calibrate the assay system, ensuring consistent and accurate ACTH measurements across tests. Model 025221 and 025321 are part of this set, providing traceable calibration levels that align with clinical chemistry standards. These calibrators are essential for maintaining precision in ACTH quantification, particularly when comparing results over time or across different batches of reagents.
How does the regulatory pathway for this device ensure its suitability for clinical chemistry diagnostics?
The ST AIA-PACK ACTH and its calibrator sets have undergone FDA 510(k) clearance and comply with the In Vitro Diagnostic Device Directive (IVDD), confirming they meet established clinical chemistry standards. The device was reviewed by the FDA’s Clinical Chemistry (CH) Advisory Committee and deemed substantially equivalent to a predicate device, validating its performance, safety, and intended use for quantitative ACTH measurement in human plasma. This regulatory route ensures the assay’s reliability for diagnostic applications.
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. Sources consulted: ST AIA-PACK ACTH | | Tosoh Bioscience, PDF AIA-PACK ACTH CONTROL SET - Tosoh, St Aia-pack Acth, and St Aia-pack Acth Calibrator Set Model 025221 and ..., Calibrator Set ST AIA-Pack® Adrenocorticotropic - McKesson
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 | K111335 | Class II | Active |
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Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (3)
- FDA 510(k) K111335 24 fields · synced Sep 18, 2026
- FDA UDI 8395d105-c3e0-479e-a9e2-2a47854a0dcd 34 fields · synced May 30, 2026
- EUDAMED 87a0dc67-e3df-4abe-bda3-b982af0bcd45 61 fields · synced Jul 8, 2026