(8 days)
Architect TSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Architect TSH MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect TSH MasterCheck Levels 1, 2, 3 and 4 contain TSH (human) prepared in TRIS buffer with protein (bovine) stabilizers.
Preservative: Sodium Azide.
This document is a 510(k) summary for the Bio-Rad Laboratories Architect TSH MasterCheck. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding specific study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit "acceptance criteria" in the traditional sense of a performance study with specific metrics (e.g., sensitivity, specificity, accuracy) and corresponding thresholds. Instead, it compares the characteristics of the Bio-Rad Architect TSH MasterCheck with a predicate device to establish substantial equivalence.
The table below illustrates the comparison provided in the document:
| Characteristic | Architect TSH MasterCheck | Casco Standards Document Serum Multi-Analyte Verification Test Set (Predicate) |
|---|---|---|
| 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 | TRIS buffer with protein (bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | TSH | Multiple |
| Open Vial Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the Architect TSH assay | Calibration verifier for multiple analytes. |
Reported Device Performance: The document implicitly states that the device is "substantially equivalent" to the predicate, implying that its performance for its intended use (verification of sensitivity, calibration linearity, and reportable range) is comparable to the predicate device. However, specific quantitative performance metrics (e.g., how accurately it verifies linearity, or what are the limits of its sensitivity verification) are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document describes the device and compares its characteristics to a predicate, but it does not detail a specific performance study with a distinct "test set" and corresponding sample size.
- Data Provenance: Not applicable in the context of an independent performance study. The data provided are descriptive of the device's composition and intended use, and comparative information to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This document is a 510(k) summary focused on substantial equivalence. It does not describe a study involving expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
- Not applicable. There is no described test set or adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document is for an in vitro diagnostic control material (a verification test set), not an imaging or diagnostic algorithm that would typically be evaluated in an MRMC study with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. The device is a TSH MasterCheck, a control material, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable. The document describes a control material used for verifying the performance of an Abbott Architect i System. The "ground truth" in this context would refer to the expected values of the TSH levels in the control material, which are manufactured and assigned during the production process. The document does not elaborate on how these "ground truth" values for the control material itself were established, though it implies the TSH (human) is prepared in a buffer.
8. The Sample Size for the Training Set
- Not applicable. This document describes a control material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is relevant to this device's description.
In summary, this 510(k) document is for a medical device that serves as a control material. Its regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device by comparing intended use, form, matrix, storage, analytes, and open vial claims. It does not present a detailed clinical or performance study with the specific metrics and methodologies often associated with novel diagnostic algorithms or imaging devices.
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NOV 2 5 1998
Image /page/0/Picture/1 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 displayed in white text on a black, rounded rectangular background. The text "BIO-RAD" is written in a bold, sans-serif font, with a plus sign between "BIO" and "RAD".
Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
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 TSH 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 Architect TSH 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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Blo-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect TSH MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect TSH MasterCheck Levels 1, 2, 3 and 4 contain TSH (human) prepared in TRIS buffer with protein (bovine) stabilizers.
Preservative: Sodium Azide.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect TSH MasterCheck and the devices to which substantial equivalence is claimed.
| Architect TSH MasterCheck | 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 | TRIS buffer with protein(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | TSH | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect TSH assay | Calibration verifier formultiple analytes. |
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized human figure with three arms or extensions reaching upwards. The text is arranged in a circular fashion around the symbol.
NOV 25 J
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984072 Trade Name: Architect TSH MasterCheck Regulatory Class: I Product Code: 75 JJX Dated: November 10, 1998 Received: November 16, 1998
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 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 regulatory 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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Paqe 2
This letter will allow you to beqin 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 diaqnostic 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 Autman
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 TSH MasterCheck
Indications for Use:
Architect TSH 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 | K984072 |
| 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.