(28 days)
K891691/A
Not Found
No
The document describes a quality control material for laboratory testing and makes no mention of AI or ML.
No
This device is a quality control urine used to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No
The device is a quality control material intended to monitor the precision of laboratory testing procedures, not to diagnose a patient's condition.
No
The device description clearly states it is prepared from human urine and 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 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 a quality control material used in laboratory testing.
- Device Description: The description mentions it's "prepared from human urine with added trace elements, heavy metals and other chemical compounds." This indicates it's a reagent or material used in vitro (outside the body) to assess the performance of diagnostic tests.
- Intended User / Care Setting: The intended user is "laboratory testing procedures," which is the environment where IVDs are used.
The fact that it's a quality control material used in a laboratory setting to monitor the performance of diagnostic tests for analytes in urine clearly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lyphochek Urine Metals Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Product codes
DIE
Device Description
Lyphochek Urine Metals Control is prepared from human urine with added trace elements, heavy metals and other chemical compounds. 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 testing procedures
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K891691/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the date 4/16/99 written in black ink at the top of the image. Below the date is the logo for BIO-RAD in a bold, sans-serif font. The logo is black with a white outline and a black background.
aboratories
990928
alifornia 92618-201 ne: (949) 598-1
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 March 18, 1999
Device (Trade & Common Name) Lyphochek Urine Metals Control
Classification Name Class I, 91DIE CFR 862.3280: Materials, Heavy Metals Control
Devices to Which Substantial Equivalence is Claimed Lyphochek Urine Metals Control Bio-Rad Laboratories Irvine, California K891691/A
Statement of Intended Use
Lyphochek Urine Metals Control is intended for use as an assayed quality control urine 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. The logo is in black and white, with the words "BIO-RAD" in large, bold letters. The letters are white, and the background is black. The logo is surrounded by a black border.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Lyphochek Urine Metals Control is prepared from human urine with added trace elements, heavy metals and other chemical compounds. 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 Urine Metals Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Lyphochek Urine Metals
Control
New Submission | Bio-Rad Lyphochek Urine Metals
Control
Prior Submission |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | An assayed quality control urine to monitor
the precision of laboratory testing procedures
for the analytes listed in the package insert. | An assayed quality control urine to
monitor the precision of laboratory
testing procedures for the analytes
listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human urine. | Human urine. |
| Storage | 2-8°C | 2-8°C |
| Open Vial
Claim | 5 days when stored tightly capped at 2-8°C. | 5 days when stored tightly capped
at 2-8°C. |
| Differences | Domestic and International products have been combined. Same claims as the substantially equivalent device plus claims for:
Hippuric Acid, Mandelic Acid,
Pentachlorophenol, Phenol,
Phenylglyoxylic Acid, and Trichloroacetic Acid. | Domestic and International products are separate. Refer to substantially equivalent package insert. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three faces.
APR 1 6 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re: K990928
Trade Name: Lyphochek Urine Metals Control Regulatory Class: I Product Code: DIE Dated: March 18, 1999 Received: March 19, 1999
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 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.
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 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 Dutman
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
Kagogy 8 510(k) Number:
Device Name: Lyphochek Urine Metals Control
Indications for Use:
Lyphochek Urine Metals Control is intended for use as an assayed quality control urine 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
| Prescription Use | ✓ |
|---|---|
| ------------------ | -------------- |
OR Over-The Counter Use