(9 days)
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
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.
This document is a 510(k) summary for the Architect Total ß-hCG MasterCheck, a control device used for verifying sensitivity, calibration linearity, and reportable range on the Abbott Architect i System. As a control product, the document does not contain information about clinical studies with human participants or an AI device. Therefore, many of the requested categories related to clinical studies are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format as would be seen for a diagnostic or therapeutic device. Instead, it focuses on the intended use and technological characteristics for substantial equivalence to a predicate device. The performance is implied by its intended use for "verification of sensitivity, calibration linearity, and reportable range."
| Feature/Characteristic | Architect Total ß-hCG MasterCheck (Reported Performance) | Casco Standards Document Serum Multi-Analyte Verification Test Set (Predicate Device) |
|---|---|---|
| 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. Sample size used for the test set and the data provenance
Not applicable. This is a control product, not a diagnostic device involving patient data. Performance is evaluated through laboratory testing of the control material itself, and the documentation does not specify a "test set" in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a control product is established through characterization of its known concentration, not expert consensus on patient cases.
4. Adjudication method for the test set
Not applicable. See point 3.
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
Not applicable. This is a control product, not an AI-powered diagnostic intended for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a control product, not an algorithm.
7. The type of ground truth used
For a control product, the "ground truth" would be the assigned value (concentration) of the analyte (Total ß-hCG) within each level of the MasterCheck. This is established through rigorous analytical methods and calibration against primary standards. The document states that Levels 1, 2, 3, and 4 contain ß-hCG (human) prepared in HEPES buffer with protein stabilizers, implying these are spiked or manufactured to specific concentrations.
8. The sample size for the training set
Not applicable. This is a control product, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
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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-hCGMasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range on theAbbott Architect i System. | In vitro diagnostic use in thequantitative determination oflinearity, calibrationverification and verificationof reportable range usingautomated, semi-automatedand 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 VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect Total ß-hCG assay | Calibration verifier formultiple analytes. |
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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 |
|---|---|
| ------------------ | ------------------------- |
§ 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.