(18 days)
Not Found
No
The summary describes a liquid control product for verifying the performance of a PSA assay, with no mention of AI or ML technology.
No
The device is described as "liquid products prepared from HEPES buffer with protein (bovine), constituents of human origin, stabilizers and preservatives" and is "intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECT System." This indicates it's a quality control material for an in vitro diagnostic assay, not a device used for treatment or diagnosis of a disease or condition.
No
This device is described as a "MasterCheck" and is intended for use in the verification of sensitivity, calibration linearity, and reportable range of Free PSA and Total PSA assays. It's used to check the performance of other assays/systems, not to diagnose a patient directly.
No
The device description explicitly states it is a "liquid product" and describes its composition, indicating it is a physical reagent, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for "verification of sensitivity, calibration linearity and reportable range of the Free PSA assay" and "verification of sensitivity, calibration linearity and reportable range of the Total PSA assay". These are activities performed in vitro (outside the body) to ensure the proper functioning of diagnostic assays.
- Device Description: The description mentions "constituents of human origin" and being a "liquid product prepared from HEPES buffer with protein (bovine)". This aligns with the nature of materials used in in vitro diagnostic testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K990393; Architect Progesterone MasterCheck) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic" in the intended use, the function and context of the device as a "MasterCheck" for verifying the performance of diagnostic assays firmly place it within the category of IVDs.
N/A
Intended Use / 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. 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.
Product codes
JJY
Device Description
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).
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
m chan
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Division Sign-Off
Office of In Vitte Diagnostic Office Evaluation and Safety
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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 MasterCheck
Architect 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 Laboratories
Architect Free PSA MasterCheck
Architect PSA MasterCheck
(New Device) | Abbott Laboratories
Architect Progesterone MasterCheck
(Predicate Device K990393) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Free PSA MasteCheck is intended for
use in the verification of sensitivity,
calibration linearity and reportable
range of the Free PSA assay on the
Abbott ARCHITECT System | Progesterone MasteCheck is intended for use in the
verification of sensitivity, calibration linearity and
reportable range of the Progesterone assay on the
Abbott ARCHITECT System . |
| | Total PSA MasteCheck is intended for
use in the verification of sensitivity,
calibration linearity and reportable range
of the total PSA assay on the Abbott
ARCHITECT 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°C
Until expiration date | 2°C to 8°C
Until 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.