(28 days)
No
The document describes a calibrator set for an immunoassay, which is a chemical reagent used to standardize the measurement of a substance. There is no mention of any computational algorithms, data analysis, or learning processes that would indicate the use of AI or ML. The description focuses on the chemical composition and stability of the calibrator.
No
This device is an In Vitro Diagnostic (IVD) calibrator set used to calibrate an assay, not to treat a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay."
No
The device description clearly indicates it is a set of physical calibrator solutions (liquids and lyophilized) used with a specific analyzer, not a software-only product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first line explicitly states "The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only". This is the most direct indicator.
- Purpose: The device is a calibrator set for an assay that measures C-peptide. Assays that measure substances in biological samples (like C-peptide in serum, plasma, or urine, as mentioned in the stability study) are typically IVDs.
- Context: The device is designed for use with a specific assay (ST AIA-PACK C-Peptide II assay) and on specific analyzers (Tosoh AIA System Analyzers), which are themselves used for in vitro diagnostic testing.
- Predicate Device: The predicate device listed (K951848) is also a calibrator set for a C-Peptide assay, further supporting the IVD nature of this device.
Therefore, based on the provided information, the ST AIA-PACK C-Peptide II Calibrator Set is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.
Product codes
JIT
Device Description
ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid).
ST AIA-PACK C-Peptide II Calibrator (2) 0.5 ng/mL (approx.) Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
ST AIA-PACK C-Peptide II Calibrator (3) 2 ng/mL (approx.) Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
ST AIA-PACK C-Peptide II Calibrator (4) 6 ng/mL (approx.) Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
ST AIA-PACK C-Peptide II Calibrator (5) 15 ng/mL (approx.) Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
ST AIA-PACK C-Peptide II Calibrator (6) 33 ng/mL (approx.) Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
P/N # 025383
The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Systems Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary of Stability Studies: Three different lots of ST AIA-PACK C-Peptide II Calibrator Set were used as samples for the shelf life stability study. Each specimen was assayed in 5 replicates and the mean and CV % were calculated. The study was initiated within one month from manufacture the evaluated reagents, then assayed at 3, 6, 9, 12 and 13 months after the day of the first assay. The criterion for recovery was within 100 +/- 10%. The criterion for reproducibility (CV %) was
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Tosoh Bioscience, Inc.
510(k) Summary
ST AIA-PACK C-Peptide II Calibrator Set
Date: Submitter:
March 11, 2014 Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123
Contact Person:
Robert L. Wick Regulatory Specialist 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 Phone: 650-636-8117 650-636-8121 Fax: Email: Robert.Wick@Tosoh.com
Device Name: Classification:
ST AIA-PACK C-Peptide II Calibrator Set Class II JIT Clinical Chemistry 21 CFR 862.1150
Predicate Device:
K951848 Tosoh Bioscience, Inc. (previously known as Tosoh Medics, Inc.) ST AIA-PACK C-Peptide (Calibrator Set)
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510(k) Summary
ST AIA-PACK C-Peptide II Calibrator Set
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Device Description:
2 x 1 mL
ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid).
2 x 1 mL
| ST AIA-PACK C-Peptide II Calibrator (2) | 0.5 | ng/mL (approx.) |
|---|---|---|
| ST AIA-PACK C-Peptide II Calibrator (3) | 2 | ng/mL (approx.) |
| ST AIA-PACK C-Peptide II Calibrator (4) | ି | ng/mL (approx.) |
| ST AIA-PACK C-Peptide II Calibrator (5) | 15 | ng/mL (approx.) |
| ST AIA-PACK C-Peptide II Calibrator (6) | 33 | ng/mL (approx.) |
| Protein matrix containing the assigned concentration of C-peptide (described on | ||
| each vial) (Lyophilized). | ||
ST AIA-PACK C-Peptide II Calibrator Set
P/N # 025383
The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Svstem Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.
Device Intended Use:
The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.
2
Tosoh Bioscience, Inc.
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK C-Peptide II Calibrator Set and the Tosoh ST AIA-PACK C-Peptide Calibrator Set
Similarities
| Characteristic | Tosoh AIA-PACK C-Peptide II
Calibrator Set | Predicate
Tosoh AIA-PACK C-Peptide
Calibrator Set (K951848) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ST AIA-PACK C-Peptide II
Calibrator Set is intended for In Vitro
Diagnostic Use Only for the
calibration of the ST AIA-PACK C-
Peptide II assay. | The AIA-PACK C-Peptide Calibrator
Set is intended for In Vitro
Diagnostic Use Only for the
calibration of the ST AIA-PACK C-
Peptide Assays. |
| Analyte | C-Peptide | C-Peptide |
| Analyzer | Tosoh AIA Systems | Tosoh AIA Systems |
| Levels | Six
(0, 0.5, 2, 6, 15, 33
ng/mL approximately) | Six
(0, 0.5, 2.0, 6.0, 15.0, 30
ng/mL approximately) |
| Format | Lyophilized
Six bottles, one for
each of the six calibrator
levels | Lyophilized
Six bottles, one for
each of the six calibrator
levels |
| Storage | Store upright and refrigerate at
2 to 8°C | Store upright and refrigerate at
2 to 8°C |
| Stability
(unopened vial) | Stable until the expiration date
stated on the label when stored at
2 - 8°C | Stable until the expiration date
stated on the label when stored at
2 -8°C |
| Shelf-life | 12 months when stored unopened
and refrigerated at 2-8°C | 12 months when stored unopened
and refrigerated at 2-8°C |
| Calibration Stability | Stable up to 90 days | Stable up to 90 days |
3
| Predicate | |||
|---|---|---|---|
| Characteristic | Tosoh AIA-PACK C-Peptide II | ||
| Calibrator Set | Tosoh AIA-PACK C-Peptide | ||
| Calibrator Set (K951848) | |||
| Base | Contains sucrose | Does not contain sucrose | |
| Stability | |||
| (opened vial) | Vial is stable at 2 - 8°C for | ||
| 1 day after initial use | Vial is stable at 2 - 8°C for | ||
| 7 days after initial use |
Differences
Summary of Traceability
The ST AIA-PACK C-Peptide II Calibrator Set contains assigned concentrations of Cpeptide. The assigned value is determined on a lot-by-lot basis and is designed to provide an assay calibration range of 0.02 to 30 ng/mL of C-peptide. The calibrators in this set have been standardized against WHO 1ª IRP 84/510.
Summary of Stability Studies
Three different lots of ST AIA-PACK C-Peptide II Calibrator Set were used as samples for the shelf life stability study. Each specimen was assaved in 5 replicates and the mean and CV % were calculated. The study was initiated within one month from manufacture the evaluated reagents, then assayed at 3, 6, 9, 12 and 13 months after the day of the first assay. The criterion for recovery was within 100 +/- 10%. The criterion for reproducibility (CV %) was Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."