(32 days)
Not Found
No
The summary describes a chemical reagent kit for verifying the performance of an assay, with no mention of AI or ML technology in its intended use, device description, or any other section.
No
The device is described as being for "verification of sensitivity, calibration linearity, and reportable range" of an assay, indicating it's a quality control material for laboratory tests, not a device used to provide therapy to a patient.
No
The device is a control/calibrator used to verify the performance of a diagnostic assay (B12 assay) on an existing diagnostic system (Abbott Architect i System). It does not directly diagnose a condition but rather ensures the accuracy of the diagnostic test itself.
No
The device description clearly states that the device contains physical components (borate buffer, protein stabilizers, cyanocobalamin, antimicrobial agent) and is intended for use in verifying an assay on a physical system (Abbott Architect i System). This indicates it is a reagent or control material, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is for "verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System." This indicates it's used to assess the performance of a diagnostic test (the B12 assay).
- Device Description: The description details the composition of the different levels of the MasterCheck, which are reagents used in a laboratory setting to perform the verification.
- 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, as predicate devices are typically other IVD products.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device isn't directly diagnosing a patient, it's a critical component used to ensure the accuracy and reliability of a diagnostic test (the B12 assay), which falls under the scope of IVDs.
N/A
Intended Use / Indications for Use
Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.
Product codes (comma separated list FDA assigned to the subject device)
75JJX
Device Description
Architect B12 MasterCheck Level 0 contains borate buffer with protein (bovine) stabilizers.
Architect B12 MasterCheck Levels 1, 2, 3 and 4 contain cyanocobalamin prepared in borate buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
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
K98-1676
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in all caps and reads "BIO-RAD".
Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: (949) 598-1200
JAN 29 10000
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 18, 1998
Device (Trade & Common Name) Architect B12 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 B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 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 black rectangle with rounded corners, and the words "BIO-RAD" are written in white letters inside the rectangle. The letters are bold and sans-serif, and the plus sign between "BIO" and "RAD" is slightly larger than the other letters.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect B12 MasterCheck Level 0 contains borate buffer with protein (bovine) stabilizers.
Architect B12 MasterCheck Levels 1, 2, 3 and 4 contain cyanocobalamin prepared in borate 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 B12 MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect B12 MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the B12
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 | Borate buffer with protein
(bovine) stabilizers. | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | B12 | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect B12 assay. | Calibration verifier for
multiple analytes. |
2
Public Health Service
JAN 29 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories ECS 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984626
Trade Name: Architect B12 MasterCheck Model #6C09-5 Regulatory Class: I Product Code: 75 JJX Dated: December 21, 1998 Received: December 28, 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 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 (OS) 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
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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: 184600 Architect B12 MasterCheck Device Name:
Indications for Use:
Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory C 510(k) Number
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
OR Over-The Counter Use