(19 days)
Not Found
No
The summary describes a quality control material for a laboratory assay, not a device that processes data or images using AI/ML.
No
This device is a verification test set used to check the performance of a Free T3 assay on an Abbott Architect i System, not to treat a medical condition.
No
Explanation: This device is a "MasterCheck" and is used for verifying the "sensitivity, calibration linearity, and reportable range" of an assay, indicating it is a control or calibration material for laboratory instruments, not a device used to diagnose a patient.
No
The device description explicitly states that the device contains human serum and Free T3 prepared in human serum, indicating it is a physical reagent, not software.
Based on the provided information, the Architect Free T3 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 of the Free T3 assay on the Abbott Architect i System." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The description mentions it contains "human serum" and "Free T3 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 a verification test set, further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically other IVD devices.
While it doesn't directly diagnose a patient condition, it is a critical component used with an IVD assay (the Free T3 assay) to ensure the accuracy and reliability of the diagnostic results. Devices used for quality control, calibration, and verification of diagnostic tests are considered IVDs themselves.
N/A
Intended Use / Indications for Use
Architect Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay on the Abbott Architect i System.
Product codes
JJX
Device Description
Architect Free T3 MasterCheck Level 0 contains human serum. Architect Free T3 MasterCheck Levels 1, 2 and 3 contain Free T3 prepared in human serum.
Preservative: Sodium Azide.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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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
DEC 2 2 1998
K9843/9
Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is in white text on a black background. The text is in a bold, sans-serif font. The logo is slightly distorted, with the letters appearing to be stretched horizontally.
Bio-Rad Laboratories
A Jamnimo Road e, 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 December 02, 1998
Device (Trade & Common Name) Architect Free T3 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 Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay on the Abbott Architect i System.
1
Image /page/1/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 a simple, bold design that features the company name in white letters against a black background. The logo is easily recognizable and is used on a variety of Bio-Rad products and marketing materials.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device Architect Free T3 MasterCheck Level 0 contains human serum. Architect Free T3 MasterCheck Levels 1, 2 and 3 contain Free T3 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 Free T3 MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Free T3 MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the Free T3
assay 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 | Free T3 | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Free T3 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 stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEC 2 2 1998
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: K984319 Trade Name: Architect Free T3 MasterCheck Regulatory Class: I Product Code: JJX Dated: December 2, 1998 December 3, 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 leqally 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 aqainst 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 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 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 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: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect Free T3 MasterCheck
Indications for Use:
Architect Free T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free T3 assay 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 | K984319 |
| Prescription Use | ✓ |
|---|---|
| OR Over-The Counter Use |