(29 days)
Not Found
No
The device is a control set for an in vitro diagnostic assay, consisting of buffered bovine serum albumin with assigned levels of C-peptide. The description focuses on the chemical composition, stability, and value assignment of the control material, with no mention of AI or ML technologies.
No.
This device is an In Vitro Diagnostic (IVD) control set used for quality control procedures with an assay, not for treating or diagnosing patients.
Yes
The Intended Use / Indications for Use section explicitly states, "The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only..."
No
The device description clearly states it is a "Control Set" containing buffered bovine serum albumin with assigned levels of C-peptide, which are physical substances used for quality control in an in vitro diagnostic assay. This is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The document explicitly states "The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only". This is the most direct indicator.
- Purpose: The device is used for "performing quality control procedures with the ST AIA-PACK C-Peptide II assay." Quality control materials are essential components of in vitro diagnostic testing to ensure the accuracy and reliability of the assay results.
- Device Description: The description details the composition of the controls (buffered bovine serum albumin containing C-peptide) and how they are used in the context of the C-peptide assay.
- Performance Studies: The document includes summaries of stability and value assignment studies, which are typical performance evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K111335; Tosoh Bioscience, Inc. ST AIA-PACK ACTH (Control Set)) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
Based on these points, the AIA-PACK C-Peptide Control Set clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
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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, 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
Fax: 650-636-8121
Email: Robert.Wick@Tosoh.com |
| Device Name:
Classification: | AIA-PACK C-Peptide Control Set
Class I, reserved
JJX
Clinical Chemistry
21 CFR 862.1660 |
| Predicate Device: | K111335
Tosoh 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:
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.
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-Peptide
Control Set | Tosoh AIA-PACK ACTH Control
Set (K111335) |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The AIA-PACK ACTH Control Set is
intended for In Vitro Diagnostic Use
Only for performing quality control
procedures with the ST AIA-PACK
ACTH 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-Peptide
Control Set | Tosoh AIA-PACK ACTH Control
Set (K111335) |
|----------------------------|------------------------------------------------------------|---------------------------------------------------------|
| Controls
Concentrations | Two levels at approximately 2 and
20 ng/mL of C-Peptide | Two levels at approximately 50 and
300 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