(27 days)
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
This 510(k) submission is for the Triage® TOX Drug Screen Controls, which are assayed materials used to monitor the performance of drug screen tests. This device is not an AI-powered diagnostic tool, but rather a quality control material for laboratory use. Therefore, many of the requested categories related to AI performance, such as human reader improvement with AI, standalone AI performance, and AI training data, are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria or performance metrics for the Triage® TOX Drug Screen Controls. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "Summary of Comparison Data" section compares the characteristics of the new device to two predicate devices.
| Characteristic | Triage® TOX Drug Screen Controls | Reported Device Performance (as compared to predicates) |
|---|---|---|
| Intended Use | Assayed control for monitoring urine-based drugs of abuse assays | Matches predicate devices |
| Matrix | Human Urine | Matches predicate devices |
| Form | Liquid | Matches predicate devices |
| Analytes | Commonly abused drugs | Matches predicate devices |
| Storage | -20 °C or colder | Differs from predicate devices (2-8 °C) |
The difference in storage temperature is noted but not presented as a failure to meet an acceptance criterion. The overall conclusion is that the device is substantially equivalent, implying that its performance as a quality control material is deemed acceptable for its intended use, similar to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the submission. As a quality control material, the "test set" would typically refer to internal validation data, which is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. For a quality control material, the "ground truth" would likely be established through chemical analytical methods or certified reference materials, rather than expert consensus on diagnostic images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable/provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic algorithm.
7. The Type of Ground Truth Used
For a quality control material like this, the "ground truth" for its contained analytes would typically be established through analytical testing methods traceable to reference standards, rather than expert consensus, pathology, or outcomes data in the context of diagnostic interpretation. The document does not explicitly state how the "ground truth" (i.e., the certified values of the control material) was established.
8. The Sample Size for the Training Set
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
Triage® TOX Drug Screen Controls
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: (To be determined)
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 11030 Roselle StreetSan Diego, CA 92121 |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 9/4/01 |
B. Device Names
-
- Trade Name
Triage® TOX Drug Screen Controls
-
- Common / Usual Name
Not Applicable
3. Classification Name
Quality Control Material (Assayed and Unassayed) 21 CFR 862:3280 Class | Product Code: DIF
C. Predicate Devices
BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)
D. Device Description and Intended Use
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
{1}------------------------------------------------
E. Summary of Comparison Data
| Characteristic | Triage® TOX DrugScreen Controls | Bio-RadLiquicheck | Dade BehringEmit |
|---|---|---|---|
| Intended Use | Assayed control formonitoring urine-based drugs ofabuse assays | Assayed control formonitoring urine-based drugs ofabuse assays | Assayed control formonitoring urine-based drugs ofabuse assays |
| Matrix | Human Urine | Human Urine | Human Urine |
| Form | Liquid | Liquid | Liquid |
| Analytes | Commonly abuseddrugs | Commonly abuseddrugs | Commonly abuseddrugs |
| Storage | -20 °C or colder | 2-8 °C | 2-8 °C |
The table below provides a comparison of the technical principles between the Triage® TOX Drug Screen Controls and the predicate devices.
F. Conclusion
The information provided in the premarket notification demonstrates that the Triage® TOX Drug Screen Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Controls are safe and effective for their intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.
OCT - 3 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Jeffrey R. Dahlen Principal Scientist Biosite Diagnostics, Inc. 11030 Roselle Street San Diego, CA 92121
Re: K012999
Trade/Device Name: Triage® TOX Drug Screen Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I, reserved Product Code: DIF Dated: September 5, 2001 Received: September 6, 2001
Dear Dr. Dahlen:
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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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 -
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 nonification. The I 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 1 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, (Joase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Butman
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 (if known): {to-be-determined} Ko12999
Device Name: Triage® TOX Drug Screen Controls
Indications For Use:
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kuria Alexander Sr. Juan Lopez
Division Sign Off
(Division Sign-O)
Division of Clinical Laboratory Devices
510(k) Number K012999
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
§ 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.