(49 days)
Not Found
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML technologies.
No
The device is described as an assayed quality control serum for monitoring the precision of laboratory testing procedures, not for treating a disease or condition.
No
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device is a physical control serum (lyophilized human serum with added constituents) used in laboratory testing, not a software application.
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 "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This is a classic function of an IVD, which is used to test samples taken from the human body (in this case, the control serum itself, which is used to validate the testing of patient samples).
- Device Description: It's a "quality control serum" prepared from human serum. Quality control materials are essential components of IVD testing workflows.
- Predicate Device: The mention of a predicate device (K940433; Lyphochek Tumor Marker Control) strongly suggests that this device is being compared to a previously cleared IVD, further indicating its classification as an IVD.
- Intended User / Care Setting: "laboratory testing procedures" points to a clinical laboratory setting where IVD testing is performed.
While the document doesn't explicitly state "In Vitro Diagnostic," the combination of its intended use, description as a quality control serum, and the mention of a predicate device used in laboratory testing procedures clearly aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
JJY
Device Description
Lyphochek Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
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
laboratory
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
DEC 1 6 1998
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in white, bold, sans-serif letters. The text is set against a black, rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation October 27, 1998
Device (Trade & Common Name) Lyphochek Tumor Marker Control
Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed
Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, CA K940433
Statement of Intended Use
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.
Description of the Device
Lyphochek Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.
DEC 16 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diaqnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re: K983807 Lyphochek Tumor Marker Control Trade Name: Requlatory Class: I Product Code: JJY Dated: October 27, 1998 Received: October 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 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 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 requlations 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 Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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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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 labelinq requlation (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 qeneral 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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510(k) Number: __K983807 Device Name: Lyphochek Tumor Marker Control
Indications for Use:
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 this package insert.
Peter E. Mclain
(Div. in Off)
Div. al Laboratory Devices K983807
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use ✓
OR Over-The Counter Use _