(8 days)
Not Found
No
The device description and intended use indicate it is a verification test set for an existing system, not a system that processes data or makes decisions using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as MasterCheck, used for verifying sensitivity, calibration linearity, and reportable range of a system, not for treating any medical condition.
No
The device is described as a "MasterCheck" intended for verifying sensitivity, calibration linearity, and reportable range of a system, not for diagnosing a condition in a patient.
No
The device description explicitly states that the device contains physical components (TRIS buffer, protein stabilizers, TSH, Sodium Azide) and is intended for use in verifying the performance of a physical laboratory instrument (Abbott Architect i System). This indicates it is a physical reagent or control, not a software-only device.
Based on the provided information, the Architect TSH 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 another diagnostic device (the Architect i System) which is used to test patient samples.
- Device Description: The description details the components of the product, which are reagents and materials used in a laboratory setting for testing purposes.
- Predicate Device: The mention of a predicate device (K950469; Casco Standards Document Serum Multi-Analyte Verification Test Set) further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and they are typically other IVDs.
While the document doesn't provide details about patient samples or clinical outcomes, its function as a control or verification material for a diagnostic system firmly places it within the realm of In Vitro Diagnostics.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
75JJX
Device Description
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
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
1
Image /page/1/Picture/3 description: The image shows the logo for BIO-RAD. The logo is white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.
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 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 | 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. |
2
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.
3
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
4
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 |
|---|---|
| ------------------ | ------------------------- |