(87 days)
The TPSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Total Prostate Specific Antigen method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
The TPSA 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.
The Total PSA Calibrator is a five-level product. Levels 1,2,4,5, and 6 contain 0.0, 4.0, 20.0, 50.0, and 108.0 ng/mL PSA, respectively. Level 1 is a horse serum base with no detectable PSA. Levels 2,4,5 and 6 contain a human prostate specific antigen (free PSA) in a bovine serum albumin base. Bottle values are assigned according to the process outlined in Appendix B. Level 3 is reserved for use with future methods and will not be included in the packaging at this time.
The provided text describes a "Total Prostate Specific Antigen Calibrator" which is an in vitro diagnostic product intended to be used to calibrate the Total Prostate Specific Antigen method for the Dimension® clinical chemistry system. This type of device is a calibrator, not a medical imaging or AI-driven diagnostic device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth types are not applicable in the context of typical AI/imaging device evaluations.
The document focuses on demonstrating substantial equivalence to a predicate device (PSA Calibrator for Dimension® clinical chemistry system) rather than proving performance against specific acceptance criteria in a clinical study. Substantial equivalence for calibrators typically involves demonstrating similar intended use, analyte, matrix, form/storage, values, and levels.
Here's an attempt to address the questions based on the available information, noting the inapplicability of many:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical performance study for an AI device. Instead, the "performance" is demonstrated through a comparison to a predicate device, showing substantial equivalence.
| Feature | Acceptance Criteria (from predicate comparison) | Reported Device Performance (Total Prostate Specific Antigen Calibrator) |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human PSA | Human PSA |
| Matrix | Level 1 Horse Serum, Levels 2-5 BSA | Level 1 Horse Serum, Levels 2,4,5,6 BSA |
| Form/Storage | Frozen (-10°C to -20°C) | Liquid (2°C to 8°C) |
| Values | Assigned | Assigned |
| Levels | 5 levels | 5 levels |
| Packaging Config. | 1.0 mL | 2.0 mL vials, 10 vials per kit, 2 vials at each level |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a calibrator and not an AI or imaging diagnostic device evaluated with a test set of patient data. The "test set" in this context would be the calibrator materials themselves, which are described by their composition and target values.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth for a calibrator's values is established through a different process, typically involving reference methods, traceability to international standards, and internal validation procedures, not by expert consensus on clinical cases. The document mentions "Bottle values are assigned according to the process outlined in Appendix B" (Appendix B is not provided in the extract).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not the type of evaluation performed for a calibrator.
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
This information is not applicable. MRMC studies are used to evaluate diagnostic imaging devices with human readers, not calibrators.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a calibrator, not an algorithm. Its performance is inherent to its physical and chemical properties and its ability to establish reference points for an assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for calibrator values is established through assigned values based on reference methods and standardization procedures. The document states "Bottle values are assigned according to the process outlined in Appendix B." This usually means values are traceable to higher-order reference materials or internationally accepted standards for the analyte (in this case, human PSA).
8. The sample size for the training set
This information is not applicable. Calibrators do not have a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not applicable.
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Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | George M. PlummerDade Behring, Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101Phone: (302) 631-9798FAX: (302) 631-6299 |
|---|---|
| Date of Preparation: | 3/18/02 |
| Device Name: | Total Prostate Specific Antigen Calibrator |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | PSA Calibrator for Dimension® clinical chemistry system(K973100) |
Device Description'. The Total PSA Calibrator is a five-level product. Levels 1,2,4,5, and 6 contain 0.0, 4.0, 20.0, 50.0, and 108.0 ng/mL PSA, respectively. Level 1 is a horse serum base with no detectable PSA. Levels 2,4,5 and 6 contain a human prostate specific antigen (free PSA) in a bovine serum albumin base. Bottle values are assigned according to the process outlined in Appendix B. Level 3 is reserved for use with future methods and will not be included in the packaging at this time.
Intended Use: The TPSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Total Prostate Specific Antigen method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Comparison to Predicate Device:
| PSA Calibrator for Dimension® | Total Prostate Specific Antigen Calibrator for Dimension® | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human PSA | Human PSA |
| Matrix | Level 1 Horse SerumLevel 2-5 BSA | Level 1 Horse SerumLevel 2,4,5,6 BSA |
| Form/Storage | Frozen (-10°C to -20°C) | Liquid (2°C to 8°C) |
| Values | Assigned | Assigned |
| Levels | 5 levels | 5 levels |
| Packaging Configuration | 1.0 mL | 2.0 mL vials, 10 vials per kit, 2 vials at each level |
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Comments on Substantial Equivalence: The Total Prostate Specific Antigen Calibrator for the Dimension® clinical chemistry system is equivalent to the PSA Calibrator for the Dimension®. Both products contain human Prostate Specific Antigen as the analyte source and are for use as calibrators for Prostate Specific Antigen Assays.
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Conclusion: The Total Prostate Specific Antigen Calibrator for the Dimension® clinical chemistry system is substantially equivalent to the PSA Calibrator for the Dimension® based on the comparison summarized above.
G.M. Plummer
George M. Plummer Regulatory Assurance and Compliance Manager Date: March 18, 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. George M. Plummer Regulatory Assurance and Compliance Manager Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
JUN 2 1 2002
Re: K020980
Trade/Device Name: Total Prostate Specific Antigen Calibrator Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator, Secondary Regulatory Class: II Product Code: JIT Dated: June 11, 2002 Received: June 18, 2002
Dear Mr. Plummer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Device Name: Total Prostate Specific Antigen Calibrator
Indications for Use:
The TPSA 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.
G. M. Plummer
George M. Plummer Regulatory Assurance and Compliance Manager March 18, 2002
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Radia Menan
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _
§ 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.