(14 days)
Not Found
No
The document describes a control material for a laboratory assay and does not mention any AI or ML components.
No
The device is described as being for "verification of sensitivity, calibration linearity, and reportable range" of an assay, clearly indicating it is a quality control/calibration product for another diagnostic device, not a device used to treat a disease or condition in a patient.
No.
The device is intended for the verification of an assay on a diagnostic system, not for directly diagnosing medical conditions in patients. It's a quality control material for a diagnostic test.
No
The device description explicitly states that the device contains physical components (HEPES buffer, protein stabilizers, ferritin, antimicrobial agent) and is intended for use with a specific hardware system (Abbott Architect i System). It is a reagent/control material, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of sensitivity, calibration linearity, and reportable range of the Ferritin 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 Ferritin assay).
- Device Description: The description details the components of the MasterCheck, which are reagents and materials used in a laboratory setting for 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, as predicate devices are typically other IVDs.
The purpose of this device is to ensure the accuracy and reliability of a diagnostic test performed on patient samples, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
Architect Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Architect Ferritin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Ferritin MasterCheck Levels 1, 2, 3 and 4 contain ferritin (human) prepared in HEPES 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
DEC 1 7 1998
Image /page/0/Picture/2 description: The image shows the Bio-Rad logo. The logo is white text on a black rounded rectangle. The text reads "BIO+RAD" in all caps.
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 02, 1998
Device (Trade & Common Name) Architect Ferritin 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 Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin assay on the Abbott Architect i System.
1
Description of the Device
Architect Ferritin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Ferritin MasterCheck Levels 1, 2, 3 and 4 contain ferritin (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 similanties between the Bio-Rad Architect Ferritin MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Ferritin MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the Ferritin
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 | Ferritin | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Ferritin assay | Calibration verifier for
multiple analytes. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the profile images.
DEC 1 7 1998 Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K984325 Architect Ferritin MasterCheck Trade Name: Regulatory Class: I Product Code: JJY Dated: December 2, 1998 Received: December 3, 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 leqally 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 qeneral 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 Requlations, 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 Requlation (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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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
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 requlation 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 Ferritin MasterCheck
Indications for Use:
Architect Ferritin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Ferritin 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 | K984315 |
| Prescription Use | OR | Over-The Counter Use | ||
|---|---|---|---|---|
| ------------------ | ---------------------------- | ---- | ---------------------- | ---------------------------- |