(28 days)
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.
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.
This document describes the Lyphochek Urine Metals Control, a quality control urine product. It is intended to monitor the precision of laboratory testing procedures for certain analytes. The provided text is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for a diagnostic or therapeutic medical device.
The document essentially establishes "substantial equivalence" of the new Lyphochek Urine Metals Control to a previously marketed version (K891691/A). This type of submission generally doesn't require performance studies against specific acceptance criteria for safety and effectiveness in the same way a novel device would. Instead, it relies on demonstrating that the new device is as safe and effective as the predicate device.
However, I can extract the relevant information based on the typical requirements implied by your request, even if the specific details are not fully present for each point.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for a quality control product like this primarily revolves around demonstrating that it performs its intended function (monitoring precision) comparably to an existing, cleared product. Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implied to be at least as good as the predicate device, particularly for stability and intended use.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | To function as an assayed quality control urine to monitor precision of laboratory testing procedures. | "An assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." (Matches predicate device) |
| Form | Lyophilized. | Lyophilized (Matches predicate device) |
| Matrix | Human urine. | Human urine (Matches predicate device) |
| Storage | 2-8°C. | 2-8°C (Matches predicate device) |
| Open Vial Claim | 5 days when stored tightly capped at 2-8°C. | 5 days when stored tightly capped at 2-8°C (Matches predicate device) |
| Additional Analytes | Function as a quality control for new analytes (Hippuric Acid, Mandelic Acid, Pentachlorophenol, Phenol, Phenylglyoxylic Acid, and Trichloroacetic Acid) effectively. | The new submission claims these additional analytes. The implicit "performance" is that it adequately serves as a control for these analytes. No specific performance data for these analytes is provided in this summary, but would have been part of the full 510(k) submission to justify the claim of substantial equivalence for these additions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific "test set" sample sizes or data provenance in the way a clinical trial for a diagnostic device would. For substantial equivalence of a quality control product, the "test set" would primarily involve demonstrating that the new product, including its new analytes, is stable and performs as expected with laboratory instruments. This information is typically proprietary to the manufacturer and not detailed in the public 510(k) summary.
The comparison table indicates the device claims are based on combining "Domestic and International products" and adding new analytes. This suggests internal data collection for these modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the 510(k) submission of a quality control product. Ground truth, in the context of a quality control, refers to the accurately known concentrations of the analytes within the control material. This is established by the manufacturer through rigorous analytical methods and reference standards, not typically by "experts" in the sense of clinical decision-makers.
4. Adjudication Method for the Test Set
Not applicable for a quality control product.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are typically for imaging or diagnostic devices where human interpretation plays a role. This is a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical quality control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for a quality control product is the assigned value (concentration) of each analyte in the control material, established through certified reference materials or highly accurate analytical methods during manufacturing. The document doesn't explicitly state "certified reference materials" but that is the standard practice for assigning values to quality controls.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured quality control product, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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.
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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 MetalsControlNew Submission | Bio-Rad Lyphochek Urine MetalsControlPrior Submission | |
|---|---|---|
| IntendedUse | An assayed quality control urine to monitorthe precision of laboratory testing proceduresfor the analytes listed in the package insert. | An assayed quality control urine tomonitor the precision of laboratorytesting procedures for the analyteslisted in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human urine. | Human urine. |
| Storage | 2-8°C | 2-8°C |
| Open VialClaim | 5 days when stored tightly capped at 2-8°C. | 5 days when stored tightly cappedat 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. |
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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.
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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
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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
§ 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.