The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.

Device Description

2 x 2 mL AIA-PACK C-Peptide Control Level 1 Buffered bovine serum albumin containing approximately 2 nq/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. AIA-PACK C-Peptide Control Level 2 2 x 2 mL Buffered bovine serum albumin containing approximately 20 ng/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. The AIA-PACK C-Peptide Control Set contains buffered bovine serum albumin with assigned levels of C-peptide. The C-peptide controls shall be run at the beginning of each day on which C-peptide assays are scheduled.

AI/ML Overview

This document describes the TOSOH BIOSCIENCE, INC. AIA-PACK C-Peptide Control Set, a quality control material. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device and summarizing stability and value assignment studies. It does not contain information about a study proving the device meets clinical acceptance criteria for diagnostic performance, as it is a control set, not a diagnostic device itself.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable or discussed for this type of device (a quality control material).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Performance
Stability (Shelf Life)	Recovery within 100 ± 10%. Reproducibility (CV%) ≤ 10%.	6, 12, and 13 months after manufacture: Recovery was within 100 ± 10% and reproducibility (CV%) was ≤ 10%. Conclusion: Shelf life set at 12 months at 2-8°C.
Stability (In-Use, Reconstituted)	Recovery within 100 ± 10%. Reproducibility (CV%) ≤ 10%.	15 days at refrigerator temperature (2-8°C) after reconstitution: Recovery and reproducibility met acceptance criteria. Conclusion: In-use stability set at 14 days after reconstitution, provided vials are kept tightly sealed and refrigerated (2-8°C).
Value Assignment (Control Set)	Mean values fell within the value range. All CV% fell within pre-determined acceptance criteria. Assigned control value range is ± 20% of the target value. Target levels: approximately 2 ng/mL and 20 ng/mL of C-peptide.	For 2 lots of control levels 1 and 2, using two AIA 2000 analyzers: Measurements in 5 replicates showed mean values fell within the value range and all CV% fell within pre-determined acceptance criteria. The assigned concentration range is determined lot-by-lot to provide target control levels of approximately 2 and 20 ng/mL of C-peptide, with a range of +/- 20% of the target value.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Stability Studies: Three different lots of the AIA-PACK C-Peptide Control Set were used as samples for the study.
- In-Use Stability: A single lot of control set was used. Each specimen was assayed in 5 replicates.
- Value Assignment: Two lots for control levels 1 and 2 were used. Measurements were made in 5 replicates.
Data Provenance: Not explicitly stated, but clinical laboratory studies involving control materials are typically conducted internally by the manufacturer or by contract labs in the country where the manufacturer is based (USA in this case, based on the address provided). The studies described appear to be prospective studies specifically designed to assess the performance of the control set under various conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a quality control material. Its performance is assessed against defined analytical criteria (recovery, reproducibility) rather than by expert clinical interpretation. The "ground truth" for the assigned values is established through a traceable process using reference materials, not expert consensus on diagnostic images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a quality control material. Its performance is based on analytical measurements against pre-defined quantitative criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control material and not an AI-powered diagnostic device or a system intended for human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a quality control material; it does not involve an algorithm for diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the stability and in-use studies, the "ground truth" is the expected original concentration of C-peptide in the control material, against which recovery and reproducibility are measured.
For value assignment, the ground truth for the primary reference material was assigned based on C-Peptide of Human Insulin, International Reference Reagent (WHO International Reference Reagent). The secondary reference material and the control set values were then assigned using this primary reference material as a calibrator, following a hierarchical traceability scheme.

8. The sample size for the training set

Not applicable. This is a quality control material; it does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

TOSOH BIOSCIENCE, INC. ROBERT WICK REGULATORY SPECIALIST 6000 SHORELINE COURT, STE. 101 SOUTH SAN FRANCISCO CA 94080

Re: K143296

Trade/Device Name: AIA-PACK C-Peptide Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: November 15, 2014 Received: November 17, 2014

Dear Mr. Robert Wick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ruth A. Chesler -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143296

Device Name AIA-PACK C-Peptide Control Set

Indications for Use (Describe)

The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Tosoh Bioscience, Inc.

510(k) Summary (k)143296

AIA-PACK C-Peptide Control Set

Date:Submitter:	December 16, 2014Tosoh Bioscience, Inc3600 Gantz RoadGrove City, OH 43123
Contact Person:	Robert L. WickRegulatory Specialist6000 Shoreline Ct., Ste. 101South San Francisco, CA 94080Phone: 650-636-8117Fax: 650-636-8121Email: Robert.Wick@Tosoh.com
Device Name:Classification:	AIA-PACK C-Peptide Control SetClass I, reservedJJXClinical Chemistry21 CFR 862.1660
Predicate Device:	K111335Tosoh Bioscience, Inc.ST AIA-PACK ACTH (Control Set)

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510(k) Summary

AIA-PACK C-Peptide Control 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:

AIA-PACK C-Peptide Control Set

P/N # 025484

The AIA-PACK C-Peptide Control Set contains buffered bovine serum albumin with assigned levels of C-peptide. The C-peptide controls shall be run at the beginning of each day on which C-peptide assays are scheduled.

Device Intended Use:

The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.

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Substantial Equivalence:

Comparison between the Tosoh AIA-PACK C-Peptide Control Set and the Tosoh AIA-PACK ACTH Control Set

Similarities

Control Set

Parameter	Tosoh AIA-PACK C-PeptideControl Set	Tosoh AIA-PACK ACTH ControlSet (K111335)
Intended use	The AIA-PACK C-Peptide ControlSet is intended for In VitroDiagnostic Use Only for performingquality control procedures with theST AIA-PACK C-Peptide II assay.	The AIA-PACK ACTH Control Set isintended for In Vitro Diagnostic UseOnly for performing quality controlprocedures with the ST AIA-PACKACTH Assay.
Number of levels	2	2
Matrix	Buffered bovine serum albumin	Buffered bovine serum albumin
Format	Lyophilized	Lyophilized

Differences Control Set

Parameter	Tosoh AIA-PACK C-PeptideControl Set	Tosoh AIA-PACK ACTH ControlSet (K111335)
ControlsConcentrations	Two levels at approximately 2 and20 ng/mL of C-Peptide	Two levels at approximately 50 and300 pg/mL of ACTH

Traceability

Control materials were prepared from C-Peptide which was obtained from BACHEM, Product code: H-2470.1000.

Summary of Stability Studies

Three different lots of AIA-PACK C-Peptide Control Set were used as samples for the study. The study was initiated within one month from manufacture of the evaluated reagents, and then assayed at 6, 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 </= 10%. The recovery was within 100 +/- 10% and the reproducibility (CV %) was </=10% at 13 months, the shelf life of the ST AIA-PACK C-Peptide Control Set was set at 12 months at 2-8° C from the date of manufacturing.

The in use stability study for the ST AIA-PACK C-Peptide Control Set was conducted at one site using one AIA-2000 analyzer and a single lot of control set. The control set material were opened and reconstituted at day 0, 7, 8, 14 and 15 before the measurement. The reconstituted control set vials were sealed and refrigerated. Each specimen was assayed in 5 replicates. The criterion for recovery was 100 +/- 10%. The criterion for reproducibility (% CV) was </= 10%. Since the recovery and the reproducibility meet the acceptance criteria for 15 days at refrigerator temperature, the in use stability of the ST AIA-PACK C-Peptide Control Set after reconstitution, was set as 14 days.

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Tosoh Bioscience, Inc.

When stored unopened and refrigerated at 2-8 ℃, the Control Set is stable until the expiration date on the label. The controls should be used within 14 day of opening or reconstituting, provided the vials are kept tightly sealed and refrigerated at 2-8 °C.

Summary of Value Assignment

The primary reference material was prepared by diluting the C-peptide (purchased) with calibrator base and its value of C-peptide as reference material was assigned based on C-Peptide of Human Insulin, International Reference Reagent (WHO International Reference Regent) using ST AIA-PACK C-Peptide II. The value of the secondary reference material was assigned using the AIA 2000 instruments with the primary reference material as calibrator. The value was verified by comparing measured results with those obtained with the previous lot for patient samples or control materials.

The AIA-PACK C-Peptide Control Set values were assigned using the AIA 2000 instruments with the secondary reference material as calibrator. The Control set contains assigned concentration range of C-peptide. The assigned range is determined on a lot-by-lot basis and is designed to provide target control levels of approximately 2 and 20 ng/mL of C-peptide. The value assignment for the AIA-PACK C-Peptide Control was carried out using two AIA 2000 analyzers and 2 lots for control levels 1 and 2. Measurements were made in 5 replicates and mean values fell within the value range. In addition, all CV% fell within pre-determined acceptance criteria. The assigned control value range is +/- 20% of the target value for the AIA-PACK C-Peptide Control Set.

Conclusion:

The Tosoh Bioscience. Inc. AIA-PACK C-Peptide Control Set is substantially equivalent to the Tosoh Bioscience, Inc. AIA-PACK ACTH Control Set in (k) 111335 with similar intended use.

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.