(18 days)
Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECT System.
Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECT i System.
These are liquid products prepared from HEPES buffer with protein (bovine), constituents of human origin, stabilizers and preservatives. (Level 0 does not contain preservatives or constituents of human origin).
This document describes the Architect Free PSA MasterCheck and Architect Total PSA MasterCheck, which are quality control materials. The information provided does not pertain to an AI/ML device, a diagnostic device that requires ground truth from experts, or a device that would necessitate a multi-reader multi-case study. Therefore, the requested information regarding acceptance criteria and study details as they relate to AI/ML or diagnostic performance is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's stability and its intended use as a quality control material.
Device Description:
The Architect Free PSA MasterCheck and Architect Total PSA MasterCheck are liquid products prepared from HEPES buffer with bovine protein, constituents of human origin, stabilizers, and preservatives. They are intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free PSA assay and Total PSA assay, respectively, on the Abbott ARCHITECT System.
Acceptance Criteria and Device Performance (Stability Studies):
The document provides information on stability studies, which serve as a form of performance criteria for these quality control materials.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 3 days when stored tightly capped at 2°C to 8°C | 3 days when stored tightly capped at 2°C to 8°C |
| Shelf Life (Unopened) | 12 months when stored at 2°C to 8°C | 12 months when stored at 2°C to 8°C |
Other Requested Information (Not Applicable or Not Provided for this Device Type):
- Sample sized used for the test set and the data provenance: Not applicable as this is a quality control material and not a diagnostic device with a clinical "test set" in the context of patient data. The stability studies likely involved samples of the control material itself, but the specific number of units or batches tested is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for a quality control material.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not applicable for a quality control material.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not applicable as the device is not an algorithm.
- The type of ground truth used: Not applicable, as the "ground truth" for a quality control material relates to its inherent stability and accurate concentration, which is verified through laboratory testing.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document focuses on the regulatory submission for the quality control material, primarily demonstrating its substantial equivalence to a predicate device and its stability. It does not contain information typically associated with the evaluation of AI/ML or diagnostic devices using patient data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services U.S.A. The logo features a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 8 - 2004
Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-1200
Re: K042335
Trade/Device Name: Architect Free PSA MasterCheck Architect Total PSA MasterCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class II Product Code: JJY Dated: August 26, 2004 Received: August 30, 2004
Dear Ms Platt:
This letter corrects our substantially equivalent letter of September 17, 2004 regarding the Architect Free PSA MasterCheck and Architect Total PSA MasterCheck in which the Architect Total PSA MasterCheck was omitted from the listing of the trade name(s).
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 (PMA). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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.
This letter will allow you to continue marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Robert H. Becker Jr.
Robert L. Becker, Jr., M.D., Pk DIRECTOR Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K042335 |
|---|---|
| Device Name: | Architect Free PSA MasterCheck |
| Indications For Use: | Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECT System. |
| Device Name: | Architect Total PSA MasterCheck |
| Indications For Use: | Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECT i System. |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
Office of In Vitte Diagnostic Office Evaluation and Safety
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510(k) K042335
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Summary of Safety and Effectiveness Architect MasterCheck Controls (PSA and PSA Free)
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
August 26, 2004
Device Identification 2.0
Product Name:
| Product Name: | Architect Free PSA MasterCheckArchitect PSA MasterCheck | ||
|---|---|---|---|
| Common Name: | Multi-analyte Controls, (Assayed and unassayed) | ||
| Classifications: | Class I | ||
| Product Code: | JJY | ||
| Regulation Number: | 21 CFR 864.1660 |
Device to Which Substantial Equivalence is Claimed 3.0
Architect Progesterone MasterCheck Abbott Laboratories Abbott Park, IL 60064
510 (k) Number: K990393
Description of Device 4.0
These are liquid products prepared from HEPES buffer with protein (bovine), constituents of human origin, stabilizers and preservatives. (Level 0 does not contain preservatives or constituents of human origin).
Intended Use 5.0
Architect MasteChecks are intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA or Total PSA assay on the Abbott ARCHITECT | System.
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Preservatives: 6.0
Architect MasteChecks do not contain sodium azide as a preservative. They contains a Arontest Masteonoons as not cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
Comparison of the new device with the Predicate Device 7.0
The new Architect MasterCheck products claim substantial equivalence to the Architect Progesterone MasterCheck currently in commercial distribution (K990393). The new Architect MasterCheck products contain either Free PSA or Total PSA analyte.
| Characteristics | Bio-Rad LaboratoriesArchitect Free PSA MasterCheckArchitect PSA MasterCheck(New Device) | Abbott LaboratoriesArchitect Progesterone MasterCheck(Predicate Device K990393) |
|---|---|---|
| Similarities | ||
| Intended Use | Free PSA MasteCheck is intended foruse in the verification of sensitivity,calibration linearity and reportablerange of the Free PSA assay on theAbbott ARCHITECT System | Progesterone MasteCheck is intended for use in theverification of sensitivity, calibration linearity andreportable range of the Progesterone assay on theAbbott ARCHITECT System . |
| Total PSA MasteCheck is intended foruse in the verification of sensitivity,calibration linearity and reportable rangeof the total PSA assay on the AbbottARCHITECT System . | ||
| Form | Liquid | Liquid |
| Open Vial | 3 days at 2°C to 8°C | 3 days at 2°C to 8°C |
| Storage Stability(Unopened) | 2°C to 8°CUntil expiration date | 2°C to 8°CUntil expiration date |
| Differences | ||
| Matrix | HEPES buffer with protein (bovine) | Human Serum |
| Analytes | Contains the following analyte:Free PSA (Architect Free PSA MasterCheck) Total PSA (Architect Total PSA MasterCheck) | Contains the following analyte:Progesterone |
Table 1. Similarities and Differences between new and predicate device.
1.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for these products. Product claims are as follows:
- Open vial Stability: 3 days when stored tightly capped at 2 to 8°C. .
- Shelf Life: Twelve months when stored at 2 to 8 °C .
All supporting data is retained on file at Bio-Rad Laboratories.
§ 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.