(36 days)
Not Found
No
The document describes a calibration and verification material for a laboratory assay, not a device that processes data or images using AI/ML.
No.
This device is an in-vitro diagnostic control for verifying the performance of a Folate assay, not for treating a disease or condition.
No
This device is for the verification of an assay on a system, not for diagnosing patients.
No
The device description explicitly states that the device contains physical components (borate buffer, pteroyIglutamic acid, citrate buffer, protein stabilizers, antimicrobial agent) and is intended for use with a specific hardware system (Abbott Architect i System), indicating it is not software-only.
Based on the provided information, the Architect Folate MasterCheck is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of sensitivity, calibration linearity, and reportable range of the Folate 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 (the Folate assay).
- Device Description: The description details the composition of the different levels of the MasterCheck, which are reagents used in a laboratory setting.
- Predicate Device: The mention of a predicate device (K950469; Casco Standards Document Serum Multi-Analyte Verification Test Set) is common for IVD devices undergoing regulatory review, as it establishes a basis for comparison.
While the document doesn't contain information about image processing, AI, patient age, or performance studies (which are often included for diagnostic tests themselves), the core function and intended use clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Architect Folate MasterCheck is intended for use in the verification of sensitivity. calibration linearity, and reportable range of the Folate assay on the Abbott Architect i System.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Architect Folate MasterCheck Level 0 contains boratc buffer. Architect Folate MasterCheck Levels 1, 2, 3 and 4 contain pteroyIglutamic acid (PGA) prepared in citrate buffer with protein (bovine) stabilizers. Preservative: Antimicrobial Agent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/0 description: The image shows the date "FEB 2 1999". The month is abbreviated to three letters and is followed by the day and year. The text is in a simple, sans-serif font and is likely part of a larger document or record.
Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The text is white and bolded, and it is set against a black background. The background is in the shape of a rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 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 December 21, 1998
Device (Trade & Common Name) Architect Folate 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
STATUS CARDER CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSUL
Architect Folate MasterCheck is intended for use in the verification of sensitivity. calibration linearity, and reportable range of the Folate 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 plus sign is slightly smaller than the other letters. The logo is simple and recognizable.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Folate MasterCheck Level 0 contains boratc buffer. Architect Folate MasterCheck Levels 1, 2, 3 and 4 contain pteroyIglutamic acid (PGA) prepared in citrate 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 Folate MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Folate MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the Folate
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 | Citrate buffer with protein
(bovine) stabilizers. | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Folate | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Folate assay. | Calibration verifier for
multiple analytes |
2
Image /page/2/Picture/2 description: The image shows a stylized logo. The logo consists of three curved lines that are stacked on top of each other. The lines are thick and black, and they appear to be flowing or waving. The logo is oriented vertically, and it is positioned on the left side of the image.
2 1999 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re: K984625
Trade Name: Architect™ Folate MasterCheck Regulatory Class: I Product Code: 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 (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
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 (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
K984625 510(k) Number: Device Name: Architect Folate MasterCheck
Indications for Use:
Architect Folate MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Folate assay on the Abbott Architect i System.
Jean Cooper
(Division Sign-Off)
ision of Clinical Laboratory Devices K984625 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