(36 days)
Not Found
No
The 510(k) summary describes a verification test set (controls) for an estradiol assay, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is described as a "MasterCheck" used for "verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay." It is a diagnostic tool for ensuring the accuracy of a testing system, not a device intended for treating a medical condition.
No
Explanation: This device is described as a calibrator or control material used for verifying the performance of an estradiol assay, not for directly diagnosing a medical condition in a patient.
No
The device description explicitly states that the device contains physical components (TRIS buffer, protein stabilizers, estradiol, antimicrobial agent). 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 "use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbott Architect i System." This means it's used to check the performance of a diagnostic test (the Estradiol assay), which is a core function of an IVD.
- Device Description: The description details the composition of the MasterCheck materials, which are designed to be run on the Architect i System to assess the Estradiol assay's performance.
- 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 other IVDs.
While the document doesn't contain information about patient age, user setting, or performance studies (which are often found in IVD submissions), the core function of verifying the performance of a diagnostic assay firmly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Architect Estradiol MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbett Architect i System.
Product codes (comma separated list FDA assigned to the subject device)
75JJX
Device Description
Architect Estradiol MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect Estradiol MasterCheck Levels 1, 2, 3 and 4 contain estradiol prepared in TRIS 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
Image /page/0/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 black and white and features the company name in bold, sans-serif font. The logo is enclosed in a rounded rectangle.
boratories
one: (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 Estradiol 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 Estradiol MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbett Architect i System.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo consists of the text "BIO-RAD" in a bold, sans-serif font. The text is white and is set against a black, rounded rectangle.
Blo-Rad Laboratories Diagnostics Gmun Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Estradiol MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect Estradiol MasterCheck Levels 1, 2, 3 and 4 contain estradiol prepared in TRIS 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 Estradiol MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Estradiol MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the Estradiol
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 | TRIS buffer with protein (bovine)
stabilizers. | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Estradiol | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Estradiol assay. | Calibration verifier for
multiple analytes. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a stylized logo or emblem, possibly associated with a department or organization. The logo features a series of three curved, overlapping shapes that resemble stylized waves or swooshes. The text "DEPART" is oriented vertically and rotated, and the text "OF HEALTH & HUMAN" is also oriented vertically and rotated.
2 1999 EEB
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
K984604 Re:
Trade Name: Architect™ Estradiol 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 stated in also 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 Connistions 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 vitto 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 Butman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
V
Enclosure
4
Page 1 of 1
3
510(k) Number: K984604
Device Name: Architect Estradiol MasterCheck
Indications for Use:
Architect Estradiol MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Estradiol assay on the Abbott Architect i System.
Sean Cooper
u: Sign-Off) on of Clinical Laboratory Devices K984604 Ak) Mumber
(Please Do NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use \checkmark OR Over-The Counter Use __