(4 days)
Not Found
No
The summary describes a quality control material for a laboratory analyzer and does not mention any AI or ML components.
No
The device is described as being for "verification of sensitivity, calibration linearity, and reportable range." This indicates it's a quality control material used to assess the performance of a diagnostic system, not a device used to directly treat a medical condition.
No
The device is described as "intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System," indicating it is a quality control material rather than a device used to diagnose a patient's condition.
No
The device description explicitly states that the device contains human serum, indicating it is a physical reagent, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly 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.
- Device Description: The description mentions it contains "human serum" and "T4 prepared in human serum." These are biological materials used in laboratory testing.
- Predicate Device: The mention of a predicate device (K950469; Casco Standards Document Serum Multi-Analyte Verification Test Set) which is also likely an IVD, further supports this classification.
The lack of information about image processing, AI/ML, anatomical site, patient age, intended user, training/test sets, performance studies, and key metrics is typical for a device like this, which is a control or calibrator used with a diagnostic system, rather than the diagnostic system itself. Its purpose is to ensure the accuracy and reliability of the diagnostic test.
N/A
Intended Use / Indications for Use
Architect Total T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Product codes
75JJX, JJY
Device Description
Architect Total T4 MasterCheck Level 0 contains human serum Architect Total T4 MasterCheck Levels 1, 2 and 3 contain T4 prepared in human serum. 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for Bio-Rad. The logo is in white text on a black background. The text is bold and sans-serif.
ratories
ne California 92618-2017 ephone: (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 Total T4 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 Total T4 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 logo is in white text on a black background. The text is bold and sans-serif.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device Architect Total T4 MasterCheck Level 0 contains human serum Architect Total T4 MasterCheck Levels 1, 2 and 3 contain T4 prepared in human serum. 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 Total T4 MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Total T4
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 | Human serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Total T4 | Multiple |
| Open Vial | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Total T4 assay | Calibration verifier for
multiple analytes. |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
NOV 20 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re: K984074 Architect Total T4 Mastercheck Trade Name: Regulatory Class: I Product Code: JJY 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 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 requlation (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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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 requlation (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 requlation 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 Sutman
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: K98 4074
Device Name: Architect Total T4 MasterCheck
Indications for Use:
Architect Total T4 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 | K984074 |
| Prescription Use | |
|---|---|
| ------------------ | ------------- |
OR
| Over-The Counter Use | |
|---|---|
| ---------------------- | -- |