(41 days)
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No
The document describes a control material for a laboratory assay and does not mention any AI or ML components.
No
This device is for the verification of an assay on an analyzer, not for treating a condition or disease in a patient. It serves as a control or calibrator for lab equipment.
No
Explanation: The device is described as a "MasterCheck" intended for verifying the sensitivity, calibration linearity, and reportable range of a Progesterone assay on a diagnostic system. This indicates it is a control or calibrator product used to ensure the proper functioning and accuracy of a diagnostic test, rather than being a diagnostic device itself that directly provides a medical diagnosis.
No
The device description explicitly states that the device contains human serum and progesterone prepared in human serum, indicating it is a physical reagent, not software.
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 Progesterone assay on the Abbott Architect i System." This means it's used to check the performance of another diagnostic test (the Progesterone assay), which is a key characteristic of an IVD.
- Device Description: The description mentions that it contains human serum and progesterone 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) further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and they are typically IVDs themselves.
While it doesn't directly diagnose a disease, it is a crucial component in ensuring the accuracy and reliability of a diagnostic test, which falls under the scope of IVDs.
N/A
Intended Use / Indications for Use
Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.
Product codes
JJX
Device Description
Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum. Preservative: Antimicrobial Agent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 description: The image shows a handwritten date, "8/22/99", in black ink. Below the date, there is a faded, illegible stamp or marking, which appears as a blurred, textured area. The date is written with a slightly slanted style, and the stamp is positioned directly beneath it.
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 February 8, 1999
Device (Trade & Common Name) Architect Progesterone MasterCheck
Classification Name Class I, 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 Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.
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Image /page/1/Picture/0 description: The image is a black and white photograph that appears to be a landscape. The bottom portion of the image contains a series of dark, irregular shapes that could be interpreted as trees or bushes. The upper portion of the image is mostly white, suggesting a sky or a bright, featureless background.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum.
Preservative: Antimicrobial Agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Abbott Architect Progesterone MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Progesterone
MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the
Progesterone 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 | Progesterone | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Progesterone assay. | Calibration verifier for
multiple analytes. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAR 2 2 1994
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K990393 Trade Name: Architect Progesterone MasterCheck Regulatory Class: I Product Code: JJX Dated: February 8, 1999 February 9, 1999 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, Druq, 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 requlatory 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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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 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: __ K990 393 Device Name: Architect Progesterone MasterCheck
Indications for Use:
Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone 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 | K990393 |
| Prescription Use | ✓ | OR | Over-The Counter Use |
|---|---|---|---|
| ------------------ | ----------------------------------------- | ---- | ---------------------- |
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