(66 days)
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of methadone in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of methadone in urine at a cut-off concentration of 300 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing methadone at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text regarding the ACON MTD One Step Methadone Test Strip and Device, focusing on the requested information:
Acceptance Criteria and Study Details for ACON MTD One Step Methadone Test
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the agreement percentages. However, based on the presented results and the conclusion of substantial equivalence, the implicit acceptance criteria would have likely been high agreement percentages with both the predicate device and the GC/MS reference method. The reported performance is as follows:
| Performance Metric (vs. Predicate Device: LifeSign Status DS™ MTD One-Step Methadone Test) | ACON MTD Test Strip Performance | ACON MTD Test Device Performance |
|---|---|---|
| Positive Agreement (95% CI) | 100% (97% - 100%) | 100% (97% - 100%) |
| Negative Agreement (95% CI) | 100% (98% - 100%) | 100% (98% - 100%) |
| Overall Agreement (95% CI) | 100% (99% - 100%) | 100% (99% - 100%) |
| Performance Metric (vs. Reference Standard: GC/MS) | ACON MTD Test Strip Performance | ACON MTD Test Device Performance |
|---|---|---|
| Positive Agreement (95% CI) | 99% (96% - 100%) | 99% (96% - 100%) |
| Negative Agreement (95% CI) | 94% (90% - 97%) | 94% (90% - 97%) |
| Total Agreement (95% CI) | 96% (94% - 98%) | 96% (94% - 98%) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 300 clinical urine specimens.
- This included 10% of samples with methadone concentrations at -25% of the cut-off range.
- Data Provenance: The text states "clinical urine specimens," implying these were collected from a clinical setting.
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not specified, but generally, studies comparing against established methods using collected samples are retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for the test set was established by objective laboratory methods (GC/MS and comparison to a predicate device), not by expert interpretation of the test device itself.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The study compares the device's results directly against a predicate device and a reference laboratory method (GC/MS). Discrepancies would be resolved by the reference method, not by an adjudication panel interpreting the device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the device itself against established methods, not on how human readers would perform with or without AI assistance, as these are qualitative immunoassay tests read visually.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, this was a standalone performance study. The ACON MTD One Step Methadone Test Strip and Device are described as "rapid chromatographic immunoassays" with a "visual, qualitative end result" that "can be performed without the use of an instrument." The performance data presented are for the device's ability to detect methadone in urine, independent of human interpretive variability beyond simply reading a positive/negative line.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- Predicate Device Comparison: The LifeSign Status DS™ MTD One-Step Methadone Test (K991080), a previously cleared device.
- Objective Laboratory Method: Gas Chromatography/Mass Spectrometry (GC/MS) analysis at a cut-off of 300 ng/mL. GC/MS is considered a gold standard for confirming drug presence and concentration.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not specified. As this is a test kit (immunoassay) rather than a complex algorithm requiring machine learning, there might not be a distinct "training set" in the conventional sense of algorithm development. The design and optimization of the test kit itself would have been part of development, but specific training set data for performance claims are not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a traditional "training set" for an algorithm. The development of the test would involve internal validation and optimization using known positive and negative samples, but these are typically not documented as separate "ground truth" establishment for a training set in a 510(k) summary for this type of device.
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OCT 1 5 2001
8. SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS
This summary of 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 Kolla595 - Color September i
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date: August 6, 2001
Contact Person: Edward Tung, Ph.D.
Product Names:
ACON® MTD One Step Methadone Test Strip
ACON® MTD One Step Methadone Test Device
Common Name:
Immunochromatographic test for the qualitative detection of methadone in urine
Device Classification:
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are similar to other FDA-cleared devices for the qualitative detection of methadone in urine specimens. These tests are used to provide a preliminary analytical result (21 CFR 862.3620). Methadone test systems have been classified as Class II devices with moderate complexity.
Classification Name:
Methadone test system
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Intended Use:
The ACON® MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.
Description:
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of methadone in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of methadone in urine at a cut-off concentration of 300 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing methadone at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Predicate Device:
LifeSign Status DSTM MTD One-Step Methadone Test
510(k) Number: K991080
Comparison to a Predicate Device:
A comparison of the features of the ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test is shown below:
- Both tests are assays intended for the qualitative detection of methadone in urine samples. ●
- Both tests are intended as a screening method that provides a preliminary analytical test result. .
- Both tests are immunochromatographic, lateral flow assays for the rapid detection of ● methadone with a visual, qualitative end result.
- Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody ● interactions to indicate a positive or negative result.
- . Both tests have a cut-off methadone concentration of 300 ng/mL.
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Safety and Effectiveness Data:
Accuracy
A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with methadone concentrations at -25% cut-off range. This evaluation samples with memations concentrations at 25% on. On . Step Methadone Test Strip and Test Device with LifeSign Status DSM MTD One-Step Methadone Test; as well as against data Dovio with Enebig. Das Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:
ACON MTD One Step Methadone Test Strip versus LifeSign Status DSTM MTD One- Step Methadone Test:
Positive Agreement: 132 / 132 = 100% (97% - 100%) Negative Agreement: 168 / 168 = 100% (98% - 100%) Overall Agreement: 300 / 300 = 100% (99% - 100%*)
- 95% Confidence Intervals
ACON MTD One Step Methadone Test Device versus the LifeSign Status DS™ MTD One-Step Methadone Test:
Positive Agreement: 132 / 132 = 100% (97% - 100%) Negative Agreement: 168 / 168 = 100% (98% - 100%) Overall Agreement: 300 / 300 = 100% (99% - 100%*)
- 95% Confidence Intervals
ACON MTD One Step Methadone Test Strip versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%) Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
- 95% confidence intervals
ACON MTD One-Step Methadone Test Device versus GC/MS at the cutoff of 300 ng/ml:
Positive agreement with GC/MS: 122 / 123 = 99% (96% - 100%) Negative agreement with GC/MS: 167 / 177 = 94% (90% - 97%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*)
- 95% confidence intervals
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Conclusion:
These clinical studies demonstrate the substantial equivalency between the ACON MTD One Step Methadone Test Strip, ACON MTD One Step Methadone Test Device and the LifeSign Status Monadone Test Datpy Freeddone Test, which has already being marketed in the United States. It is Do - HITD One Diep Sizease tests are safe and effective in detecting methadone at a concentration also connemally demonstrated that these tests are suitable for healthcare professionals and professional point-of-care use.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 5 2001
Edward Tung, Ph.D. Director of Regulatory Affair ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
K012595 Re:
Trade/Device Name: ACON® MTD One Step Methadone Test Strip and ACON® MTD One Step Methadone Test Device Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: August 8, 2001 Received: August 10, 2001
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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 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, please 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
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INDICATIONS FOR USE 10.
510(k) Number:
Kolasgs
Device Name: ACON® MTD One Step Methadone Test Strip
ACON® MTD One Step Methadone Test Device
The ACON MTD One Step Methadone Test Strip and ACON MTD One Indications for Use: Step Methadone Test Device are rapid chromatographic immunoassays Blog Moundone in etection of Methadone in human urine at a cut-off They are intended for healthcare concentration of 300 ng/mL. professionals and professional point-of-care use.
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Kevia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012595
Or
Over-The-Counter Use_
38
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).