(23 days)
The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.
- 2 x 1 mL ST AIA-PACK PROG III Calibrator (1) 0 nq/mL Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
- 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) 0.5 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (3) 1.5 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (4) 5.0 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (5) 15 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (6) 45 ng/mL (approx.)
Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
The ST AIA-PACK PROG III Calibrator Set is designed specifically for use on the Tosoh AIA System 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 PROG III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, formatted as requested:
Acceptance Criteria and Device Performance Study for ST AIA-PACK PROG III Calibrator Set
This document describes the ST AIA-PACK PROG III Calibrator Set, a device intended for in vitro diagnostic use for the calibration of the ST AIA-PACK PROG III assay. The information provided heavily focuses on stability and value assignment studies to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Real Time Stability (Shelf Life) | Recovery: 100 +/- 10% | Supports an 8-month shelf life at 2-8°C. |
| Reproducibility (CV%): ≤ 10% | (Specific CV% values not provided for shelf life, but implied to meet criteria) | |
| Open Vial Stability | Recovery: 100 +/- 10% | Supports a 1-day reconstituted claim when stored at 2-8°C. |
| Reproducibility (CV%): ≤ 10% | (Specific CV% values not provided for open vial, but implied to meet criteria) | |
| Value Assignment Precision | Precision (CV%): Within 10% (for each calibrator level) | Cal (2): 4.8% CVCal (3): 2.2% CVCal (4): 2.2% CVCal (5): 2.0% CVCal (6): 2.9% CV |
| Value Assignment Recovery | (Not explicitly stated as an acceptance criterion for individual calibrator levels but implied by "assigned value" and "Reference Value") | Cal (2) Mean: 0.504 ng/mL (Reference: 0.5 ng/mL)Cal (3) Mean: 1.53 ng/mL (Reference: 1.5 ng/mL)Cal (4) Mean: 5.08 ng/mL (Reference: 5.0 ng/mL)Cal (5) Mean: 15.0 ng/mL (Reference: 15 ng/mL)Cal (6) Mean: 45.5 ng/mL (Reference: 45 ng/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Real Time Stability: Not explicitly stated, but calibrator sets were assayed at 3, 6, and 9 months (implied multiple samples/replicates at each time point).
- Open Vial Stability: Not explicitly stated, but samples were "reconstituted and stored... for 2 days and tested."
- Value Assignment: 5 replicates of the test calibrator were analyzed for each calibrator level (Cal 2-6).
- Data Provenance: Not specified, but generally, such studies for regulatory submission are prospective and conducted in-house or by contract research organizations under the manufacturer's control. No country of origin is explicitly mentioned for the data itself, beyond the US location of the submitter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This device is a calibrator set for an in vitro diagnostic assay, not an AI or imaging device requiring human expert ground truth. The "ground truth" for calibrators is related to the reference materials and their assigned concentrations.
- For Value Assignment: The primary reference material was USP (United States Pharmacopeia) Standard (Lot #I1J239). The progesterone value of this reference material was assigned gravimetrically, which is a chemical/analytical method, not typically involving human expert consensus in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not applicable. This is a calibrator set for an in vitro diagnostic device, and adjudication methods (like 2+1, 3+1 for medical image interpretation) are not relevant here. The evaluation relies on analytical performance criteria (recovery, CV%) against established reference values.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not an AI or imaging device; therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- The device itself is a calibrator, which is a reagent used by an instrument. Its performance is evaluated analytically, which is inherently "standalone" in the sense that its function (calibration) is determined by its chemical and physical properties and how it interacts with the instrument. There isn't an "algorithm only" performance metric in the typical sense of AI. The "algorithm" here is the assay procedure itself on the Tosoh AIA System Analyzers, and the calibrator's performance helps ensure the accuracy of that system.
7. The Type of Ground Truth Used
- Analytical/Reference Standard: The ground truth for the calibrator concentrations is established by referring to the USP (United States Pharmacopeia) Standard (Lot #I1J239). The values were assigned gravimetrically (for the primary reference material). This is a highly controlled chemical/analytical method, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This is an in vitro diagnostic calibrator, not an AI model that requires a training set of data. The "training" in this context refers to the development and manufacturing of the calibrator itself, where the concentrations are established and verified against reference standards.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" in the AI sense for this type of device. The "ground truth" for the calibrator's assigned values is based on traceability to the USP (United States Pharmacopeia) Standard (Lot #I1J239), with primary reference material values assigned gravimetrically. These are highly standardized analytical procedures to ensure accuracy and consistency. The product calibrator values were then assigned using AIA-2000 instruments with the secondary reference material as calibrator.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in a dark color.
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, SUITE 101 SOUTH SAN FRANCISCO, CA 94080
December 18, 2015
Re: K153417
Trade/Device Name: ST AIA-PACK PROG III Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: November 24, 2015 Received: November 25, 2015
Dear 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.
{1}------------------------------------------------
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For : 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K153417
Device Name ST AIA-PACK PROG III Calibrator Set
Indications for Use (Describe) The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.
Type of Use (Select one or both, as applicable)
| For activities that do NOT disturb State-owned submerged lands |
|---|
| For Construction (that disturb State-owned submerged lands) |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
{3}------------------------------------------------
510(k) Summary ST AIA-PACK PROG III Calibrator Set
SAFETY AND EFFECTIVENESS AS REQUIRED BY 1. 21 CFR 807.92
This Summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.
2. SUBMITTER NAME AND ADDRESS
Date of Summary Preparation: Submitter:
November 23, 2015 Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123
Contact Person:
Robert L. Wick Requlatory Specialist 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 Phone: 650-636-8117 Fax: 650-636-8121 Email: Robert.Wick@Tosoh.com
510K NUMBER, DEVICE PROPRIETARY NAME, 3. COMMON NAME, PURPOSE FOR THE SUBMISSION, REGULATORY CLASSIFICATION, PANEL, PRODUCT CODE, AND 21 CFR NUMBER.
510k No.: Device Proprietary Name: Purpose of Submission: Regulatory Classification Common Name: Classification: Product Code: Panel: 21 CFR Number:
ST AIA-PACK PROG III Calibrator Set New Product Calibrator, Secondary Progesterone Test System Class II JIT Clinical Chemistry 21 CFR 862.1150
{4}------------------------------------------------
PREDICATE DEVICE PROPRIETARY NAMES AND 4. 510 (K) NUMBERS
Predicate Device Number: Predicate: Manufacturer:
K933269 ST AIA-PACK PROG (Calibrator Set) Tosoh Bioscience, Inc. (previously known as Tosoh Medics, Inc.)
INTENDED USE 5.
The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.
6. DEVICE DESCRIPTION
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 PROG III Calibrator (1) 0 nq/mL
Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
| 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) | 0.5 | ng/mL (approx.) | |
|---|---|---|---|
| ST AIA-PACK PROG III Calibrator (3) | 1.5 | ng/mL (approx.) | |
| ST AIA-PACK PROG III Calibrator (4) | 5.0 | ng/mL (approx.) | |
| ST AIA-PACK PROG III Calibrator (5) | 15 | ng/mL (approx.) | |
| ST AIA-PACK PROG III Calibrator (6) | 45 | ng/mL (approx.) |
Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
ST AIA-PACK PROG III Calibrator Set
P/N # 025340
The ST AIA-PACK PROG III Calibrator Set is designed specifically for use on the Tosoh AIA System 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 PROG III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.
{5}------------------------------------------------
PREDICATE COMPARISON TABLE 7.
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK PROG III Calibrator Set and the Tosoh ST AIA-PACK PROG Calibrator Set
Similarities
| Characteristic | Predicate | |
|---|---|---|
| Tosoh AIA-PACK PROG IIICalibrator Set | Tosoh AIA-PACK PROGCalibrator Set (K933269) | |
| Intended Use | The ST AIA-PACK PROG IIICalibrator Set is intended for In VitroDiagnostic Use Only for thecalibration of the ST AIA-PACKPROG III assay. | The AIA-PACK PROG Calibrator Set is intended for In VitroDiagnostic Use Only for thecalibration of the ST AIA-PACKPROG Assays. |
| Indications for Use (sameas Intended Use) | The ST AIA-PACK PROG IIICalibrator Set is intended for In VitroDiagnostic Use Only for thecalibration of the ST AIA-PACKPROG III assay. | The AIA-PACK PROG Calibrator Set is intended for In VitroDiagnostic Use Only for thecalibration of the ST AIA-PACKPROG Assays. |
| Analyte | Progesterone | Same |
| Format | LiquidSix bottles, one foreach of the six calibratorlevels. | Same |
| Matrix | Serum and heparinized plasma | Same |
| Storage | Store upright and refrigerate at 2 to8°C. | Same |
| Stability(unopened vial) | Stable until the expiration datestated on the label when stored at 2- 8°C. | Same |
| Calibration Stability | Stable up to 90 days | Same |
| Stability(opened vial) | 24 hours (1 day) | Same |
{6}------------------------------------------------
| Characteristic | Predicate | |
|---|---|---|
| Tosoh AIA-PACK PROG IIICalibrator Set | Tosoh AIA-PACK PROGCalibrator Set (K933269) | |
| Shelf-life | 8 months when stored unopenedand refrigerated at 2-8°C | 12 months when stored unopenedand refrigerated at 2-8°C |
| Traceability | USP (United States Pharmacopeia)Standard (Lot #11J239). | Internal reference standards. |
| Base | Bovine serum | Human serum |
| Levels | Six(0, 0.5, 1.5, 5.0, 15, 45ng/mL approximately) | Six(0, 0.5, 1.5, 5.0, 20, 60ng/mL approximately) |
| Analyzer | Tosoh AIA-2000 | Tosoh AIA-1200 |
Differences
8. SUMMARY OF STABILITY STUDIES
Summary of Stability Studies
Real Time Testing
ST AIA-PACK Progesterone III Calibrator Set were stored at refrigerated temperatures and assayed at 3, 6 and 9 months after the day of the first assay.
The acceptance criteria for recovery was within 100 +/- 10%.
The criterion for reproducibility (CV %) was </= 10%.
Current Real Time Studies support a 8 month Shelf life at 2-8°C.
Open Vial Stability
Open vial stability of the ST AIA-PACK Progesterone III Calibrator Set was assessed by reconstituting the material according to the package insert. Samples were reconstituted and stored at refrigerated temperatures for 2 days and tested for progesterone.
The criterion for recovery was within 100 +/-10%.
The criterion for reproducibility (CV %) was </= 10%.
Current open vial studies support a reconstituted claim of 1 day when stored at 2-8°C.
SUMMARY OF VALUE ASSIGNMENT 9.
The ST AIA-PACK PROG III Calibrator Set contains assigned concentrations of progesterone. The assigned value is determined on a lot-by-lot basis and is designed to provide an assay calibration range of 0.1 to 40 ng/mL of progesterone. The calibrators for use with the ST AIA-PACK PROG III were referred to through the USP (United States Pharmacopeia) Standard (Lot #I1J239).
{7}------------------------------------------------
The primary reference material was prepared by diluting the USP reference material with calibrator base and the progesterone value as reference material was assigned gravimetrically.
The values of the product calibrator were assigned using the AIA-2000 instruments with the secondary reference material as calibrator. The values were verified by comparing measured results with those obtained with the previous lot for control materials.
The value assignment was determined by analyzing 5 replicates of the test calibrator on two Tosoh AIA-2000 instruments and the mean, SD and CV calculated for each lot before release to the user. The acceptance criteria states the precision measured by the CV should be within 10%.
| Progesterone(Calibrator Levels) | N | ReferenceValue(ng/mL) | Mean(ng/mL) | CV % |
|---|---|---|---|---|
| Cal (2) | 5 | 0.5 | .504 | 4.8 |
| Cal (3) | 5 | 1.5 | 1.53 | 2.2 |
| Cal (4) | 5 | 5.0 | 5.08 | 2.2 |
| Cal (5) | 5 | 15 | 15.0 | 2.0 |
| Cal (6) | 5 | 45 | 45.5 | 2.9 |
TRACEABILITY 10.
| ANALYTE | SUPPLIER | PRODUCTNUMBER | ORIGIN | SOURCE |
|---|---|---|---|---|
| Progesterone | Sigma | 11J239 | Steroid strippedand lipidstripped humanserum | ChemicalCompound |
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.
§ 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.