(24 days)
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No
The document describes a quality control serum for laboratory testing and does not mention any AI or ML components or functionalities.
No
This device is a quality control substance used to monitor the precision of laboratory testing procedures, not to treat a disease or condition in a patient.
No
This device is described as a "quality control serum" used to "monitor the precision of laboratory testing procedures," not to diagnose patients.
No
The device is a physical product (lyophilized human serum with added chemicals) intended for use as a quality control material in laboratory testing. It is not a software application.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This aligns perfectly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control, it's used within the IVD testing process.
- Device Description: It's prepared from human serum and used in a laboratory setting.
- Intended User / Care Setting: It's used in "laboratory testing procedures," which is the typical setting for IVDs.
The fact that it's a quality control serum further supports its role as an IVD component, used to ensure the accuracy and reliability of diagnostic tests.
N/A
Intended Use / Indications for Use
Quest Diagnostics Tumor Marker Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
This product is prepared from human serum with added chemicals, constituents of human and animal origin. This product is provided in Iyophilized form for added stability.
Mentions image processing
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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)
Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Tumor Marker Control. Product claims and a summary of the protocols used to establish claims are as follows:
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).
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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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Summary of Safety and Effectiveness Quest Diagnostics Tumor Marker Control
NOV - 5 2004
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
November 2, 2004
2.0 Device Identification
| Product Trade Name: | Quest Diagnostics Tumor Marker Control |
|---|---|
| Common Name: | Multi-analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 864.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K011579
4.0 Description of Device
This product is prepared from human serum with added chemicals, constituents of human and animal origin. This product is provided in Iyophilized form for added stability.
5.0 Intended Use
Quest Diagnostics Tumor Marker Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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Comparison of the new device with the Predicate Device 6.0
Quest Diagnostics Tumor Marker Control claims substantial equivalence to the Lyphochek Tumor Marker Control currently in commercial distribution (K011579).
| Table 1. Similarities and Differences between new and predicate device. | |||
|---|---|---|---|
| Characteristics | Quest Diagnostics
Tumor Marker Control
(New Device) | Bio-Rad Laboratories
Lyphochek Tumor Marker Control
(Predicate Device K011579) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Quest Diagnostics Tumor Marker Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | Lyphochek Tumor Marker 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. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Serum | Human Serum |
| Preservatives | Does not Contains preservatives | Does not Contains preservatives |
| Storage (Unopened) | 2°C to 8°C
Until expiration date | 2°C to 8°C
Until expiration date |
| Reconstituted Vial Claim | 14 days at 2°C to 8°C | All analytes will be stable for 14 days at 2 to 8°C, with the following exceptions: Ferritin and CA 27-29 will be stable for 6 days. ACTH, Free PSA, PSA, and Calcitonin should be assayed immediately following reconstitution |
| After Reconstituting and Freezing | All analytes 30 days at -10 to -20°C | All analytes 30 days at -10 to -20°C |
| Differences | | |
| Analytes | Contains the following analytes:
CA 15-3CA 125CA 19-9CA 27.29 [Footnote #2 listed in chart]Does not contain the following analytes:
ACTHAFP (Alpha Fetoprotein)AldosteroneBeta-2-MicroglobulinCA 50CA 72-4CalcitoninCASACEA (Carcinoembryonic Antigen)CYFRA 21-1FerritinhCG (Human Chorionic Gonadotropin)hCG - Beta SubunitNSE (Neuron Specific Enolase)PAP (Prostatic Acid Phosphatase)Prolactin | Contains the following analytes:
ACTHAFP (Alpha Fetoprotein)AldosteroneBeta-2-MicroglobulinCA 15-3CA 19-9CA 27-29CA 50CA 72-4CA 125CalcitoninCASACEA (Carcinoembryonic Antigen)CYFRA 21-1FerritinhCG (Human Chorionic Gonadotropin)hCG - Beta SubunitNSE (Neuron Specific Enolase)PAP (Prostatic Acid Phosphatase)ProlactinPSA (Prostate Specific Antigen) |
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Tumor Marker Control. Product claims and a summary of the protocols used to establish claims are as follows:
- Open vial Stability: 14 days at 2 to 8°C. .
- After reconstituting and freezing: 30 days at -10 to -20°C.
- . Shelf Life: Three years and three months when stored at 2 to 8 °C
All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle, with three curved lines forming its body and wings. The eagle is facing to the right.
Public Health Service
NOV - 5 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories. QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K042815
Trade/Device Name: Quest Diagnostics Tumor Marker Control Levels 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 5, 2004 Received: October 12, 2004
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D., Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO42815 510(k) Number (if known): Quest Diagnostics Tumor Marker Control Device Name: Quest Diagnostics Turnor Marker Control is intended for use as a quality control Indications For Use: serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Mono M Clan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042815