(15 days)
Not Found
No
The summary describes a quality control material for a drug profiling system, not the system itself. There is no mention of AI or ML in the description of the control material.
No
The device is described as a quality control urine for a drug profiling system, indicating it is used for testing and calibration, not for treating a condition or disease.
No
Explanation: The device is a quality control urine for a drug profiling system, not a device used to diagnose a condition or disease in a patient.
No
The device description clearly states it is a prepared human urine control provided in lyophilized form, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "quality control urine for the REMEDi HS Drug Profiling System." This system is used to test for drugs in urine, which is a biological sample.
- Device Description: It's prepared from "human urine with added therapeutic drugs and drugs of abuse." This confirms it's a reagent used in the testing of a human sample.
- Predicate Device: The predicate device listed, "Lyphochek Urine Toxicology Control," is also a control used in toxicology testing, which falls under the umbrella of IVDs.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is a control and not directly used for diagnosis, it is an essential component of an IVD system (the REMEDi HS Drug Profiling System) and is used to ensure the accuracy and reliability of the diagnostic testing. Therefore, it is considered an IVD itself.
N/A
Intended Use / Indications for Use
Lyphochek REMEDi Control is intended for use as a quality control urine for the REMEDi HS Drug Profiling System.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
Lyphochek REMEDi Control is prepared from human urine with added therapeutic drugs and drugs of abuse. 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
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
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is 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 shows a partial view of the Bio-Rad logo. The logo is in black and white, with the letters "BIO-RAD" visible. The letters are bold and sans-serif. The logo is likely part of a larger document or advertisement.
JUN 24 1997
Bio-Rad
Laboratories
ECS Division 26 E. Miraloma Avenue naheim. CA 92806 obona (714) 630-6400 all Free (800) 854-673.
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383
Contact Person Elizabeth Platt
Date of Summary Preparation June 5, 1997
Device (Trade & Common Name) Lyphochek REMEDi Control
Classification Name Class I, CFR 862.3280: Drug Mixture Control 91DIF
Devices to Which Substantial Equivalence is Claimed Lyphochek Urine Toxicology Control Bio-Rad Laboratories, ECS Division Anaheim, CA K881989
Statement of Intended Use
Lyphochek REMEDi Control is intended for use as a quality control urine for the REMEDi HS Drug Profiling System.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in a rounded rectangle shape. The words "BIO-RAD" are written in white letters on a black background.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Lyphochek REMEDi Control is prepared from human urine with added therapeutic drugs and drugs of abuse. 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 REMEDi Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Laboratories
Lyphochek REMEDI Control | Bio-Rad Laboratories Lyphochek
Urine Toxicology Control |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Lyphochek REMEDI Control is
intended for use as a quality
control urine for the REMEDi HS
Drug Profiling System. | Lyphochek Urine Toxicology
Control is intended for use as a
quality control urine to monitor the
performance of an individual
laboratory's broad-scren testing of
drugs of abuse in urine. |
| Levels | Two | One |
| Form | Lyophilized | Lyophilized |
| Open
Vial | 30 Days at 2-8°C | 10 Days at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
2
Image /page/2/Picture/10 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
Elizabeth Platt Staff Requlatory Affairs Representative Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, California 92806
K972174 Re : Lyphochek REMEDi Control Requlatory Class: II Product Code: DIF June 5, 1997 Dated: Received: June 9, 1997
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 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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in 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.
3
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 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 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/dsmamain.html".
Sincerely yours,
Steven Litman
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
4
Page 1 of 1
510(k) Number: ---------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name: Lyphochek REMEDi Control
Indications for Use:
Lyphochek REMEDi Control is intended for use as a quality control urine for the REMEDi HS Drug Profiling 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 | K972174 |
| Prescription Use | |
|---|---|
| ------------------ | -- |
OR Over-The Counter Use
28