(15 days)
Lyphochek REMEDi Control is intended for use as a quality control urine for the REMEDi HS Drug Profiling System.
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.
This document, K972174, is a 510(k) premarket notification for a medical device called "Lyphochek REMEDi Control." This device is a quality control urine for the REMEDi HS Drug Profiling System. The document focuses on establishing substantial equivalence to a predicate device, "Lyphochek Urine Toxicology Control (K881989)", rather than detailing specific performance studies with acceptance criteria for a new clinical efficacy claim. Therefore, many of the requested categories about acceptance criteria, study design, and performance metrics for a diagnostic device algorithm are not directly applicable or available in this submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This 510(k) submission is for a quality control material, not a diagnostic device or algorithm with performance metrics like sensitivity, specificity, accuracy, etc. The document asserts "substantial equivalence" based on similar technological characteristics and intended use, rather than demonstrating clinical performance against predefined acceptance criteria for a specific outcome.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) focuses on the chemical composition and intended use of a quality control material and its similarity to a predicate device. It does not describe a test set or data provenance for evaluating device performance as a diagnostic tool.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth establishment for a diagnostic test set is not relevant to this submission for a quality control material.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are used in clinical studies to establish ground truth for test sets, which is not described in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic device or AI on human reader performance, which is not the purpose of this 510(k) for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This submission is for a quality control material, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. Ground truth, in the context of clinical diagnostic performance, is not discussed in this submission. The "truth" for this device revolves around its chemical composition and stability as a control material, which is implied by its manufacturing process rather than a specific ground truth study.
8. The Sample Size for the Training Set
Not applicable. This submission is about a quality control material and does not involve machine learning algorithms requiring training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth establishment for it.
Summary of the Study and Substantial Equivalence:
The document describes the Lyphochek REMEDi Control as a quality control urine prepared from human urine with added therapeutic drugs and drugs of abuse, provided in lyophilized form.
The study that "proves" the device meets acceptance criteria is fundamentally a comparison to a predicate device to establish substantial equivalence, rather than a performance study with explicit acceptance criteria for diagnostic accuracy.
The comparison is presented in a table (refer to section {1} of the input) highlighting the similarities between the Lyphochek REMEDi Control and the predicate device, Lyphochek Urine Toxicology Control (K881989).
Key comparative characteristics for establishing substantial equivalence were:
- Intended Use: Both are intended for use as quality control urine. The submitted device specifies for the REMEDi HS Drug Profiling System, while the predicate is for broad-screen testing of drugs of abuse in urine. The FDA determined this was substantially equivalent.
- Levels: The submitted device has two levels, while the predicate has one. This difference was accepted.
- Form: Both are lyophilized.
- Open Vial Stability: The submitted device has 30 days at 2-8°C, while the predicate has 10 days at 2-8°C. This difference was accepted.
- Matrix: Both use human urine.
- Storage: Both require 2-8°C.
The FDA's decision (section {2} and {3} of the input) indicates that they reviewed the 510(k) notification and determined the device is "substantially equivalent ... to devices marketed in interstate commerce prior to May 28, 1976." This determination, based on the comparative information provided by Bio-Rad, served as the "proof" for market clearance rather than a separate clinical performance study with predefined acceptance criteria.
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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 LaboratoriesLyphochek REMEDI Control | Bio-Rad Laboratories LyphochekUrine Toxicology Control | |
|---|---|---|
| IntendedUse | Lyphochek REMEDI Control isintended for use as a qualitycontrol urine for the REMEDi HSDrug Profiling System. | Lyphochek Urine ToxicologyControl is intended for use as aquality control urine to monitor theperformance of an individuallaboratory's broad-scren testing ofdrugs of abuse in urine. |
| Levels | Two | One |
| Form | Lyophilized | Lyophilized |
| OpenVial | 30 Days at 2-8°C | 10 Days at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
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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.
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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 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
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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
§ 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.