(30 days)
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No
The document describes a calibration and verification material for a laboratory analyzer, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is for the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System, making it a diagnostic tool, not a therapeutic one.
No
This device is a 'MasterCheck' product used for the verification of sensitivity, calibration linearity, and reportable range on a laboratory system, not for diagnosing medical conditions in patients. It's a quality control/calibration material.
No
The device description explicitly states it contains bovine serum and testosterone prepared in bovine serum, indicating it is a physical reagent, not software.
Based on the provided information, the Architect Testosterone MasterCheck is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic system that measures a substance (testosterone) in biological samples.
- Device Description: The description mentions it contains "bovine serum" and "testosterone prepared in bovine serum." These are components used in laboratory testing to mimic or represent biological samples.
- Predicate Device: The mention of a predicate device (K950469; Casco Standards Document Serum Multi-Analyte Verification Test Set) which is also a "verification test set" further supports its classification as an IVD, as predicate devices are typically similar IVDs already cleared by regulatory bodies.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and nature of the product strongly align with the definition of an IVD device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, it's used to ensure the accuracy of a system that performs such examinations.
N/A
Intended Use / Indications for Use
Architect Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Product codes (comma separated list FDA assigned to the subject device)
75JJX
Device Description
Architect Testosterone MasterCheck Level 0 contains bovine serum Architect Testosterone MasterCheck Levels 1, 2 and 3 contain testosterone prepared in bovine serum.
Preservative: Antimicrobial agent.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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NOV 1 2 1998
Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
4983578
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation November 2, 1998
Device (Trade & Common Name) Architect Testosterone MasterCheck
Classification Name Class I. 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed
Document Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME K950469
Statement of Intended Use Architect Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
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Image /page/1/Picture/0 description: The image shows the Bio-Rad logo. The logo is white text on a black background. The text is in a bold, sans-serif font.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Testosterone MasterCheck Level 0 contains bovine serum Architect Testosterone MasterCheck Levels 1, 2 and 3 contain testosterone prepared in bovine serum.
Preservative: Antimicrobial agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect Testosterone MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Testosterone
MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range on the
Abbott Architect i System. | In vitro diagnostic use in the
quantitative determination of
linearity, calibration
verification and verification
of reportable range using
automated, semi-automated
and manual methods. |
| Form | Liquid | Liquid |
| Matrix | Bovine serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Testosterone | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect testosterone assay | Calibration verifier for
multiple analytes. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three profiles facing right, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories, Irvine Facility Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re : K983578 Architect Testosterone MasterCheck Trade Name: Product Code: Regulatory Class: F JJX צביר I Dated: October 9, 1998 Received: October 13, 1998
Dear Ms. Platt:
NOV 1 2 1998
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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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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Page 2
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Routman
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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Page 1 of 1
510(k) Number: K983578
Device Name: Architect Testosterone MasterCheck
Indications for Use:
Architect Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
OR Over-The Counter Use _
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number k98557
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