(66 days)
Not Found
No
The document describes a quality control serum for laboratory testing, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
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 "Intended Use / Indications for Use" states that the device is "intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures," not to diagnose a condition or disease in a patient.
No
The device is a physical control serum, not a software application.
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, serum) to provide information about a person's health.
- Device Description: The description mentions it's prepared from "human serum," which is a biological sample.
- Intended User / Care Setting: It's intended for "laboratory testing procedures," which is where IVDs are used.
The fact that it's a quality control serum for tumor markers further reinforces its role in diagnostic testing performed in a laboratory setting.
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 (comma separated list FDA assigned to the subject device)
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
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
laboratory
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)
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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.
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).
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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.
0
SEP - 2 1999
Image /page/0/Picture/2 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is in white, bold, sans-serif font. The text is inside of a black rounded rectangle.
aboratories
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 June 25, 1999
Device (Trade & Common Name) Lyphochek Tumor Marker Control
Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Control, All Kinds (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California K983807
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.
1
Image /page/1/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 a bold, sans-serif font. The plus sign in the middle of the name is slightly larger than the other letters. The logo is simple and recognizable.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
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.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Tumor Marker Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Lyphochek Tumor Marker
Control (New Device) | Bio-Rad Lyphochek Tumor Marker
Control (Substantially Equivalent
Device) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | An assayed quality control serum to
monitor the precision of laboratory
testing procedures for the analytes
listed in the package insert. | 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 |
| Storage | 2-8°C | 2-8°C |
| Open Vial
Claim | • 14 days when stored tightly
capped at 2-8°C, with the following
exceptions: ACTH, Free PSA, PSA
and Calcitonin should be assayed
immediately following
reconstitution.
• 30 days after reconstituting and
freezing at -10°C to -20°C with the
following exceptions: (1) PSA will
be stable for 20 days when stored
frozen at -10°C to -20°C and (2)
ACTH and Calcitonin do not have
frozen stability claims. | • 14 days when stored tightly
capped at 2-8°C, with the following
exceptions: ACTH, Free PSA, PSA
and Calcitonin should be assayed
immediately following
reconstitution.
• 30 days after reconstituting and
freezing at -10°C to -20°C with the
following exceptions: (1) PSA will
be stable for 20 days when stored
frozen at -10°C to -20°C and (2)
ACTH and Calcitonin do not have
frozen stability claims. |
| Differences | Same analytes as the substantially
equivalent device and additional
claims for the following : CA 50,
CA 195, CA 549 and CASA. | Refer to attached substantially
equivalent device product insert. |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP -2 1999
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
K992172 Trade Name: Lyphochek Tumor Marker Control Regulatory Class: I Product Code: JJY Dated: June 25, 1999 Received: June 28, 1999
Dear Ms. Platt:
Re:
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 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 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.
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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 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 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 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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Page 1 of 1
510(k) Number: ______________________________________________________________________________________________________________________________________________________________ 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 the package insert.
(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 | K992172 |
Prescription Use
ﻨﮯ
2
1994
OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________