(34 days)
Not Found
No
The summary describes a calibration and verification material for a laboratory assay, not a device that processes data or makes decisions using AI/ML.
No
This device is intended for the verification of laboratory assay performance (sensitivity, calibration linearity, and reportable range) and not for treating a disease or condition.
No
This device is a "MasterCheck" used for "verification of sensitivity, calibration linearity, and reportable range of the CEA assay". It is a quality control material which ensures the accuracy and reliability of diagnostic tests (CEA assay), but it does not perform a diagnosis itself.
No
The device description explicitly states that the device contains physical components (HEPES buffer, protein stabilizers, CEA (human), antimicrobial agent). This indicates it is a physical reagent, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "verification of sensitivity, calibration linearity, and reportable range of the CEA 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 CEA assay).
- Device Description: The description details the components of the MasterCheck, which are reagents and materials 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 legally marketed IVDs.
While the document doesn't contain information about image processing, AI, patient demographics, or performance studies, the core function and description align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Architect CEA MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Architect CEA MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect CEA MasterCheck Levels 1, 2, 3 and 4 contain CEA (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
A table is provided below comparing the similarities between the Bio-Rad Architect CEA MasterCheck and the devices to which substantial equivalence is claimed.
| Architect CEA MasterCheck | Casco Standards Document Serum Multi-Analyte Verification Test Set | |
|---|---|---|
| Intended Use | Verification of sensitivity, calibration linearity, and reportable range of the CEA 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 | HEPES buffer with protein (bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | CEA | Multiple |
| Open Vial Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the Architect CEA assay. | Calibration verifier for multiple analytes. |
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).
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/0 description: The image shows a black and white abstract pattern. The pattern is composed of small, irregular shapes and lines, creating a textured appearance. The contrast between the black and white areas is high, making the pattern visually striking. The overall effect is somewhat chaotic and organic.
K 940608
Image /page/0/Picture/2 description: The image shows the date 3/30/99 written in black ink at the top. Below the date is the logo for BIO-RAD, with the company name in bold, black letters. The logo is enclosed in a black rounded rectangle.
Bio-Rad Laboratories
500 Jeronimo F vine California 92618-20 elephone: (949) 598-12
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 February 23, 1999
Device (Trade & Common Name) Architect CEA 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 CEA MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System.
1
Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. 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 CEA MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect CEA MasterCheck Levels 1, 2, 3 and 4 contain CEA (human) prepared in HEPES 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 CEA MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect CEA MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the
CEA 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 | HEPES buffer with protein
(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | CEA | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect CEA assay. | Calibration verifier for
multiple analytes. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/10 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 an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines.
MAR 300 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re: K990608 Trade Name: Architect™ CEA MasterCheck Regulatory Class: I Product Code: JJX Dated: February 23, 1999 Received: February 24, 1999
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.
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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 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: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect CEA MasterCheck
Indications for Use:
Architect CEA MasterCheck is intended for use in the verification of Arenitoot OEA Mactor Should Shourity, and reportable range of the CEA 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 | K990608 |
| Prescription Use | OR Over-The Counter Use | |
|---|---|---|
| ------------------ | ---------------------------------------------- | ------------------------- |