(9 days)
Not Found
No
The document describes a quality control material for a laboratory analyzer and does not mention any AI or ML components.
No
The device is a MasterCheck and is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System, not for treatment or therapy.
No
The device is a MasterCheck intended for verifying the performance of a separate diagnostic system (Abbott Architect i System) by checking sensitivity, calibration linearity, and reportable range. It does not perform a diagnosis itself, but rather provides reference materials for quality control.
No
The device description clearly states it contains physical components (HEPES buffer, protein stabilizers, ß-hCG) and is intended for use with a specific hardware system (Abbott Architect i System), indicating it is not software-only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
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 another diagnostic device (the Architect i System) which is used to test biological samples.
- Device Description: The description mentions it contains "ß-hCG (human)" and is used with the "Abbott Architect i System." This further supports its role in the diagnostic process, specifically related to measuring a human analyte (ß-hCG) using a laboratory instrument.
- Predicate Device: The mention of a predicate device (K950469; Casco Standards Document Serum Multi-Analyte Verification Test Set) which is also a verification/calibration product, strongly suggests that this type of device falls under the IVD category.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use and nature of the product align perfectly with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In this case, it's used to ensure the accuracy and reliability of a system that performs such diagnostic tests.
N/A
Intended Use / Indications for Use
Architect Total ß-hCG MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Product codes
75JJX
Device Description
Architect Total ß-hCG MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers. Architect Total ß-hCG MasterCheck Levels 1, 2, 3 and 4 contain ß-hCG (human) prepared in HEPES buffer with protein (bovine) stabilizers. Preservative: Antimicrobial agent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
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)
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
Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in white text on a black background. The text is in a bold, sans-serif font. The logo is simple and recognizable.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: (949) 598-1200
JC984073
NOV 25 1998
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 10, 1998
Device (Trade & Common Name) Architect Total ß-hCG MasterCheck
Classification Name Class 1, 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 ArchitectTotal ß-hCG MasterCheck is intended for use in the verification of sensitivity,
calibration linearity, and reportable range on the Abbott Architect i System
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is in white, bold, sans-serif font. The text is set against a black, rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Total ß-hCG MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Total ß-hCG MasterCheck Levels 1, 2, 3 and 4 contain ß-hCG (human) prepared in HEPES buffer with protein (bovine) stabilizers.
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 Total ß-hCG MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Total ß-hCG
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 | HEPES buffer with protein
(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Total ß-hCG | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Total ß-hCG assay | Calibration verifier for
multiple analytes. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol. The logo is simple and recognizable, conveying the department's role in public health and welfare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 25 1998
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984073
Trade Name: Architect Total β-hCG MasterCheck Requlatory Class: I Product Code: 75 JJX Dated: November 10, 1998 November 16, 1998 Received:
Dear Ms. Platt:
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 Regulations, 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 requlations.
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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 Butman
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: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect Total β-hCG MasterCheck
Indications for Use:
Architect Total ß-hCG 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)
| | (Division Sign Off)
Division of Clinical Laboratory Devices |
|---------------|----------------------------------------------------------------|
| 510(k) Number | K984013 |
| Prescription Use | OR Over-The Counter Use |
|---|---|
| ------------------ | ------------------------- |