(98 days)
Not Found
No
The document describes a quality control product for laboratory testing and does not mention any AI or ML components.
No
Explanation: The device is explicitly stated to be "For In Vitro Diagnostic Use Only" and is intended as a control serum to monitor the precision of laboratory testing procedures for tumor markers. It is a quality control product, not a device used for treating patients.
No
The device is a quality control product used to monitor the precision of laboratory testing procedures, not to diagnose medical conditions in patients. It assesses laboratory performance rather than a patient's health status.
No
The device is a quality control product for in vitro diagnostic tests, which is a physical substance (serum) used to monitor laboratory procedures, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only."
- Purpose: The device is intended to "monitor the precision of laboratory testing procedures" for various tumor markers. This is a classic function of an IVD control product, used to ensure the accuracy and reliability of diagnostic tests performed in vitro (outside the body).
- Device Description: The description reinforces its role in assessing "laboratory's procedures and personnel techniques" and assuring "consistent performance of the testing systems within the clinical range," all of which are related to the quality control of IVD tests.
- Predicate Devices: The listed predicate devices are also IVD control products, further confirming the device's classification.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
Product codes
JJY
Device Description
Not Found
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
Clinical and Hospital laboratories
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc.". The logo consists of a stylized graphic on the left, followed by the company name in a clear, sans-serif font. The word "FUJIREBIO" is on the top line, and "Diagnostics, Inc." is on the line below.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K101809
Submitter Information
OCT - 5 2010
| Address: | |
|---|---|
| ---------- | -- |
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Stacey Dolan
(610) 240-3843
dolans@fdi.com |
| Summary preparation date: | October 5, 2010 |
Name of Device
| Trade/Proprietary Name: | Fujirebio Diagnostics Tumor Marker Control |
|---|---|
| Common/Usual Name: | Quality control material (assayed and unassayed). |
| Regulation Number: | 21 CFR 862.1660 |
| Regulatory Class: | Class I, reserved |
| Product Code: | JJY |
Fujirebio Diagnostics, Inc.
Predicate Device
Bio-Rad Lyphochek® Tumor Marker Plus Control (K082036) For HE4: ARCHITECT HE4 Control Kit (K093957)
Summary and Principle
This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.
1
Image /page/1/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a geometric shape with a combination of solid and patterned areas. The text "FUJIREBIO" is in a bold, outlined font, and below it, "Diagnostics, Inc." is in a smaller, regular font.
Intended Use
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
Statement of Substantial Equivalence
The Fujirebio Diagnostics Tumor Marker Control is intended for use as a quantitative, assayed control serum to monitor the procedures used in the laboratory for testing the analytes listed in the lot specific assigned values sheet.
The Fujirebio Diagnostics Tumor Marker Control is substantially equivalent to the Lyphochek Tumor Marker Plus Control*. Each of the devices are assayed quality control material and are used to monitor the precision of laboratory testing procedures for the analytes listed in their respective package insert.
*Note: For HE4, the Fujirebio Diagnostics Tumor Marker Control is substantially equivalent to the ARCHITECT HE4 Control Kit.
The regulatory submission is prepared pursuant to Title 21CFR § 862.1660.
A comparison of the features of the Fujirebio Diagnostics Tumor Marker Control and the Predicate Device are as follows:
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Image /page/2/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left, followed by the company name in a simple, sans-serif font. The word "Diagnostics, Inc." is placed below the company name in a smaller font size.
| Similarities | ||
|---|---|---|
| Fujirebio Diagnostics Tumor | ||
| Marker Control | ||
| (Proposed Device) | ||
| K101809 | Bio-Rad Lyphochek® Tumor | |
| Marker Plus Control | ||
| (Predicate Device) | ||
| K082036 | ||
| For HE4: | ||
| ARCHITECT HE4 Control Kit | ||
| K093957 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I, reserved | Class I, reserved |
| CFR section | 862.1660 | 862.1660 |
| Product Code | JJY | JJY |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | For In Vitro Diagnostic Use Only. | |
| Fujirebio Diagnostics Tumor | ||
| Marker Control is intended for use | ||
| as an assayed control serum to | ||
| monitor the precision of laboratory | ||
| testing procedures for the analysis | ||
| of AFP, CA15-3, CA19-9, CA125, | ||
| CEA, Ferritin, HE4, PSA and Free | ||
| PSA. | Lyphochek Tumor Marker Plus | |
| Control is intended for use as an | ||
| assayed quality control serum to | ||
| monitor the precision of laboratory | ||
| testing procedures for the analytes | ||
| listed in the package insert. | ||
| The ARCHITECT HE4 Controls | ||
| are used for the verification of the | ||
| accuracy and precision of the | ||
| ARCHITECT i System when used | ||
| for the quantitative determination | ||
| of HE4 antigen in human serum. | ||
| Matrix | Human Serum | Human Serum |
| (For HE4, matrix is protein buffer) | ||
| Form | Lyophilized | Lyophilized |
| (For HE4, Liquid) | ||
| Analytes | AFP, CA 15-3, CA 19-9, CA 125, | |
| CEA, Ferritin, PSA, Free PSA | AFP, CA 15-3, CA 19-9, CA 125, | |
| CEA, Ferritin, PSA, Free PSA | ||
| Stability - Reconstituted | ||
| at 2-8°C | 14 days at 2-8°C, except Free PSA | |
| which is stable for 7 days | 14 days at 2-8°C, except Free PSA | |
| which is stable for 7 days |
3 .
3
Premarket Notification (510(k)) Tumor Marker Control
Image /page/3/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc.". The logo consists of a stylized graphic on the left and the company name on the right. The graphic is composed of overlapping shapes, while the company name is written in a simple, sans-serif font.
| Differences | ||
|---|---|---|
| Fujirebio Diagnostics Tumor | ||
| Marker Control | ||
| (Proposed Device) | ||
| K101809 | Bio-Rad Lyphochek® Tumor | |
| Marker Plus Control | ||
| (Predicate Device) | ||
| K082036 |
For HE4:
ARCHITECT HE4 Control Kit
K093957 |
| Number of Levels | 2 | 3 |
| PSA Stability
(reconstituted) | Total PSA - 14 days
Free PSA - 7 days | Total PSA – 7 days
Free PSA - 7 days |
| Reconstitution Volume | 3.0 mLs | 2.0 mLs |
| Analytes | HE4 (Human Epididymis Protein 4) | ACTH, Aldosterone, Beta-2-
Microglobulin, CA 27.29,
Calcitonin, hCG, Prolactin,
Prostatic Acid Phosphatase, and
Thyroglobulin |
| Stability (unopened) | 18 months at 2-8°C | 3 years at 2-8°C
(For HE4, 9 Months) |
| Stability - Reconstituted
at 2-8°C | CEA and Total PSA 14 days at
2-8°C | CEA 11 days at 2-8°C
Total PSA 7 days at 2-8°C |
| Stability - Reconstituted
at Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K101809
Device Name: Fujirebio Diagnostics Tumor Marker Controls
QCT - 5 2010
Indications for Use:
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Keene Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101809
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