(41 days)
The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Prostate Specific Antigen (PSA) Calibrator for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is a frozen product. The Level 1 calibrator is horse serum based with no detectable PSA. Levels 2 through 5 contain human PSA-ACT in a bovine serum albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.
This document is a 510(k) premarket notification for a medical device called "Prostate Specific Antigen (PSA) Calibrator". It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical study for a diagnostic algorithm would.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against acceptance criteria for a novel device.
Therefore, many of the requested items cannot be answered from the provided text as they pertain to a type of study that was not conducted or documented here.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document describes a comparison to a predicate device, not a performance study against predefined acceptance criteria for a novel device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. No test set or clinical study data is provided.
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 present. No test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. No test set requiring adjudication is described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a calibrator for a clinical chemistry system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This device is a calibrator, a reagent used to ensure the accuracy of an analytical instrument. Its performance is evaluated through its ability to calibrate the instrument, not as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. The concept of "ground truth" for a calibrator is related to the accuracy of the analyte concentration within the calibrator itself, typically established through reference methods or certified reference materials, but this specific detail is not provided.
8. The sample size for the training set
This information is not present. There is no mention of a training set as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This information is not present. As there is no training set, this question is not applicable.
Summary of what the document does provide:
- Device Name: Prostate Specific Antigen (PSA) Calibrator
- Intended Use: To calibrate the PSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
- Predicate Device: aca® plus Prostate Specific Antigen Calibrator
- Comparison to Predicate Device: The document highlights similarities in intended use, analyte (PSA-ACT), matrices (horse serum, BSA), and states that both are manufactured using the same matrices and contain PSA-ACT as the analyte source.
- Conclusion: The PSA Calibrator for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Calibrator.
This document serves as a regulatory submission (510(k)) to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria for a novel technology.
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Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally.
KA73100
SEP 2 9 1997
DADE INTERNATIONAL
Chemistry Systems P.O. Box 6101
Newark, DE 19714
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: | Rebecca S. AyashDade International Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | 8/15/97 |
| Device Name: | Prostate Specific Antigen (PSA) Calibrator |
| Classification Name: | Calibrator, Secondary |
| Predicate Device: | aca® plus Prostate Specific Antigen Calibrator |
Device Description: Prostate Specific Antigen (PSA) Calibrator for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is a frozen product. The Level 1 calibrator is horse serum based with no detectable PSA. Levels 2 through 5 contain human PSA-ACT in a bovine serum albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.
Intended Use: PSA Calibrator is intended to be used to calibrate the PSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Comparison to Predicate Device:
| Dimension® RxL PSA Calibrator | aca® plus PSA Calibrator | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | PSA-ACT | PSA-ACT |
| Matrix | L-1 horse serumL-2-5 BSA | L-1 horse serumL-2-3 BSA |
| Form | frozen | liquid |
| Volume | 1.0 mL per vial | 3.0 mL per vial |
| Levels | 5 levels | 3 levels |
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Comments on Substantial
Equivalence: Both the PSA Calibrator for the Dimension® RxL system and the aca® plus PSA Calibrator are manufactured using the same matrices and contain PSA-ACT as the analyte source. Both products are intended to be used as calibrators for prostate specific antigen assays.
Conclusion: PSA Calibrator for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Calibrator based on the comparison summarized above.
Rebecca Slayden
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 8/15/97
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three tail feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade International Inc. Building 500, mailbox 514 P.O. Box 6101 Newark, DE 19714-6101
SEP 2 9 1997
Re: K973100 Trade Name: Prostate Specific Antigen (PSA) Calibrator Requlatory Class: II Product Code: JIT Dated: August 15, 1997 Received: August 19, 1997
Dear Ms. Ayash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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 Statement
Device Name: Prostate Specific Antigen (PSA) Calibrator
Indications for Use: The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Rebecca Scapph
Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 9/25/97
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Concurrence of CDRH, Office of Device Evaluation (ODE)
נ
K 973100
(510(k) Number
Victor E. Macher
Division Sign-Off Office of Device Evaluation
Prescription Use ✓
§ 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.