(38 days)
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor the performance of screening, semiquantitative and confirmatory drug-of-abuse testing procedures.
Urine Drug Screening Control is designed to monitor the performance of screening, semi-quantitative and confirmatory drugs-of-abuse testing procedures. Purified drugs or drug metabolites added to a human urine based matrix to provide a stable liquid control, which closely mimics drug containing human urine. The product contains <0.1% sodium azide as a preservative.
This document describes a 510(k) premarket notification for a quality control material, not a diagnostic device with performance metrics like sensitivity or specificity. Therefore, the typical acceptance criteria and study designs for diagnostic algorithms (like standalone performance, MRMC studies, or multi-reader paradigms) are not applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. The "acceptance criteria" in this context are alignment with the predicate device, and the "study" is a comparative analysis of these characteristics.
Here's the breakdown of the information as it relates to the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a quality control material and the evaluation is for substantial equivalence, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the new device matches those characteristics.
| Acceptance Criteria (Predicate Device Characteristic) | Reported Device Performance (Urine Drug Screening Control) |
|---|---|
| Intended use: Assayed control for monitoring urine assays for drugs of abuse | Assayed control for monitoring urine assays for drugs of abuse |
| Matrix: Human Urine | Human Urine |
| Form: Liquid | Liquid |
| Analytes: Common abused drugs | Common abused drugs |
| Storage: 2-8°C | 2-8°C |
| Stability: 30 days at 2-8°C, open | 30 days at 2-8°C, open (Note: Based on accelerated stability. Real time stability studies currently in progress) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to this type of submission. The device is a quality control material, not a diagnostic test that processes patient data. The "test set" in this context refers to the characteristics of the device itself and its comparison to the predicate. No patient data or clinical sample sizes are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. Ground truth, in the context of diagnostic performance, is not established for quality control materials in this manner. The "ground truth" for a quality control material is its chemical composition and performance within a laboratory assay, which is typically validated through internal and external methods by the manufacturer and reference laboratories.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic studies. This is not a human-interpreted diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study evaluates the performance of human readers, with and without AI assistance, on a set of cases. This device is a quality control material used to monitor laboratory assays, not a device interpreted by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study as understood for AI algorithms was not done. The concept of "standalone performance" doesn't directly apply to a quality control material in the same way it would to an AI diagnostic algorithm. The device's performance is assessed by its chemical stability and its ability to consistently produce expected results when used in drug screening assays, which is implied by the stability data and intended use, rather than an "algorithm only" evaluation.
7. The Type of Ground Truth Used
The "ground truth" for this device is its chemical formulation and stability characteristics, as well as its performance against predefined target values when used in laboratoryassays. This is inferred from "Purified drugs or drug metabolites added to a human urine based matrix" and the "assayed quality control material intended to monitor and evaluate the precision and the accuracy of laboratory testing procedures." This would typically be established through analytical testing and reference methods during the manufacturing process to ensure the control material contains the specified analytes at predefined concentrations.
8. The Sample Size for the Training Set
This information is not applicable. Quality control materials do not have "training sets" in the context of machine learning or AI algorithms. Their development relies on chemical formulation, stability studies, and manufacturing controls.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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Product Performance and Substantial Equivalency
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K9239 5
| Submitter: |
|---|
| SeraCare Technology, Inc. DBA Consolidated Technologies |
| 2170 Woodward Street |
| Austin, TX 78744-1832 |
| Phone: (512) 445-5100 |
| Fax: (512) 445-5515 |
Contact: Rusty Sewell Preparation date: July 13, 1999
Product name (trade & common):
Proprietary: Urine Drug Screening Control Common: Not Applicable
Classification name:
Class 1 , Product code: DIF 21 CFR 862:3280 : Quality Control Material (Assayed and Unassayed)
Predicate device:
LIQUICHEK™ URINE TOXICOLOGY CONTROLS BIO-RAD Laboratories K-971691
Device description:
Urine Drug Screening Control is designed to monitor the performance of screening, semi-quantitative and confirmatory drugs-of-abuse testing procedures.
Purified drugs or drug metabolites added to a human urine based matrix to provide a stable liquid control, which closely mimics drug containing human urine. The product contains <0.1% sodium azide as a preservative.
Intended use:
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor and evaluate the precision and the accuracy of laboratory testing procedures for the analytes listed in the package insert.
- Labeling: Vial labels see Attachment I Secondary Container label, see Attachment II Package Insert, see Attachment III
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510(k) Summary (continued)
Comparative analysis:
The table below provides a summary of the technological characteristics between Urine Drug Screening Control and the predicate device.
| DeviceCharacteristic | Urine Drug Screening Control | LIQUICHEK Urine ToxicologyControls |
|---|---|---|
| Intended use | Assayed control for monitoringurine assays for drugs of abuse | Assayed control for monitoring urineassays for drugs of abuse |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Analytes | Common abused drugs | Common abused drugs |
| Storage | 2-8°C | 2-8°C |
| Stability | 30 days at 2-8°C, open (See Note) | 30 days at 2-8°C, open |
Note: Based on accelerated stability. Real time stability studies currently in progress
Conclusions:
The information provided in the pre-market notification demonstrates that Urine Drug Screening Control is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Urine Drug Screening Control is safe and effective for the stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a partial view of a seal or emblem. The emblem features a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned above the words "DEPARTMENT" and "HUMAN", which are arranged vertically along the left side of the emblem. The overall design is circular, suggesting it may be part of a larger official seal.
AUG 26 1999
Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA. Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832
K992395 Re: Trade Name: Urine Drug Screening Control Regulatory Class: I Product Code: DIF
Dated: July 13, 1999 Received: July 19, 1999
Dear Mr. Sewell:
23
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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 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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INDICATIONS FOR USE STATEMENT
510(k) number (if known): K 99 23415
Urine Drug Screening Control Device name:
Indications for use:
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor the performance of screening, semiquantitative and confirmatory drug-of-abuse testing procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madin
(Division Sign-Division of Clinical La 510(k) Numb
Prescription √
§ 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.