(195 days)
The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is intended for prescription use only. The MEDTOX Buprenorphine Test is not for overthe-counter sale. It is not intended for use in point-of-care settings.
MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations:
Buprenorphine (Buprenorphine) BUP 10 ng/mL
The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result.
The MEDTOX® Buprenorphine Test is a rapid, single use, one-step qualitative immunochromatographic screening assay for the detection of Buprenorphine and its metabolites in human urine.
Acceptance Criteria and Device Performance for MEDTOX® Buprenorphine Test
This document outlines the acceptance criteria and the studies conducted to demonstrate the performance of the MEDTOX® Buprenorphine Test, a rapid, qualitative immunochromatographic screening assay for Buprenorphine and its metabolites in human urine.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from various studies detailed in the submission, primarily focusing on analytical sensitivity, specificity, and accuracy around the defined cutoff. Due to the qualitative nature of the test and the reporting style, acceptance criteria are inferred from the study design and expected performance for a screening device.
For the purposes of this summary, the primary acceptance criterion for a diagnostic test like this is typically to correctly identify drug-positive samples at or above the cutoff and drug-negative samples below the cutoff, with minimal false positives or false negatives.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (Precision): | For a qualitative test around a cutoff, there should be a clear distinction between negative and positive results between 50% and 150% of the cutoff concentration. Specifically, samples below the cutoff should be predominantly negative, and samples above the cutoff should be predominantly positive. Ideally, 100% agreement at 0 ng/mL and 150% of cutoff, and a gradient of positive detection between 75% and 125% of cutoff. | At Cutoff of 10 ng/mL:- 0 ng/mL: 45/45 Negative (100%)- 2.5 ng/mL (25%): 45/45 Negative (100%)- 5.0 ng/mL (50%): 45/45 Negative (100%)- 7.5 ng/mL (75%): 28 Negative, 17 Positive (37.8% Positive)- 12.5 ng/mL (125%): 4 Negative, 41 Positive (91.1% Positive)- 15.0 ng/mL (150%): 45/45 Positive (100%)This demonstrates appropriate sensitivity around the cutoff. |
| Analytical Specificity (Cross-Reactivity): | The device should generally not cross-react with structurally similar compounds at high concentrations, or with common medications/endogenous substances, to avoid false positives. Related Buprenorphine metabolites are expected to show some level of cross-reactivity. | Related Compounds:- Buprenorphine-glucuronide: Positive at 7.5 ng/mL (133% cross-reactive)- Norbuprenorphine: Positive at 50 ng/mL (20% cross-reactive)- Norbuprenorphine-glucuronide: Positive at 75 ng/mL (13% cross-reactive)Non-Reacting Opiates: All listed (Codeine, Diacetylmorphine, Hydrocodone, etc.) showed "None Detected" at 100,000 ng/mL (or highest level tested). These non-reactive opiates also did not affect expected results when spiked with Buprenorphine at 5 ng/mL and 15 ng/mL.Non-Crossreactive Endogenous Compounds & Common Drugs: None of the 13 endogenous compounds or 16 common drugs tested at high concentrations (typically 100 µg/mL) affected the expected Buprenorphine results at 5 ng/mL and 15 ng/mL. This indicates high specificity. |
| Interference (pH & Specific Gravity): | The device's performance should not be significantly affected by variations in urine pH or specific gravity within typical physiological ranges encountered in clinical samples. | pH: No interference observed; samples fortified to 5 ng/mL (negative) and 15 ng/mL (positive) gave expected results across pH 5.0, 6.0, 7.0, and 8.0. Specific Gravity: No interference observed; samples fortified to 5 ng/mL (negative) and 15 ng/mL (positive) gave expected results across specific gravity 1.003, 1.015, and 1.030. |
| Clinical Accuracy/Agreement (with LC/MS/MS): | High agreement expected with a confirmatory method (LC/MS/MS), particularly for samples near and above the cutoff. Low false positive rate for negative samples. | Overall Agreement:- Positive Agreement: 100% (72 High Positive + 8 Near Cutoff Positive = 80 samples correctly identified as Positive). - Negative Agreement: 96.1% (70 No Drug + 4 Near Cutoff Negative = 74 samples correctly identified as Negative). The report indicates 3 "Near Cutoff Negative" samples (between -50% and cutoff, i.e., between 5 and 10 ng/mL) were reported as positive by the device (potentially false positives or very low positives for a screening test). The three specific discordant samples were: total buprenorphine at 5 ng/mL, 7 ng/mL, and 9 ng/mL, all reported as positive by the MEDTOX test. Since the cutoff is 10 ng/mL, detecting positives below the cutoff represents a level of sensitivity for a screening test. The device had 0 false positives for samples with no drug. |
2. Sample Sizes and Data Provenance
-
Analytical Sensitivity (Precision) Test Set:
- Sample Size: 6 concentrations x 45 observations (triplicate testing on 5 different intervals by 3 operators) = 270 total observations.
- Data Provenance: Drug-free urine spiked with standard drug solutions. This is laboratory-controlled, not human patient data.
-
Analytical Specificity (Cross-Reactivity) Test Set:
- Sample Size:
- Cross-reacting metabolites: Tested with standards, results expressed as minimum concentration for positive result.
- Non-reacting opiates: Tested at 100,000 ng/mL, then spiked into Buprenorphine-containing urine (5 ng/mL and 15 ng/mL) in triplicate by in-house operators.
- Endogenous Compounds & Common Drugs: Spiked into Buprenorphine-containing urine (5 ng/mL and 15 ng/mL) in triplicate by in-house operators.
- Data Provenance: Laboratory-controlled samples using reference standards and drug-free urine.
- Sample Size:
-
Interference (pH & Specific Gravity) Test Set:
- Sample Size: 4 pH levels x 3 replicates; 3 specific gravity levels x 3 replicates. Each fortified with Buprenorphine at 5 ng/mL and 15 ng/mL.
- Data Provenance: Laboratory-controlled samples.
-
Clinical Accuracy Test Set:
- Sample Size: Total not explicitly stated, but derived from the table: 70 (No Drug) + 7 (Near Cutoff Negative) + 8 (Near Cutoff Positive) + 72 (High Positive) = 157 clinical urine samples.
- Data Provenance: Retrospective clinical urine samples obtained from MEDTOX® Laboratories. The country of origin is not specified but implicitly assumed to be the USA, given the FDA submission.
3. Number of Experts for Ground Truth and Qualifications
- Analytical Studies: "in-house operators" are mentioned. Their specific qualifications (e.g., years of experience, specific certifications) are not detailed.
- Clinical Accuracy Study: The ground truth was established by LC/MS/MS results. While LC/MS/MS is a highly precise analytical method, the interpretation of these results might involve expert toxicologists or lab personnel. The number and qualifications of such "experts" for LC/MS/MS confirmation are not provided, as the method itself serves as the objective reference standard.
4. Adjudication Method for the Test Set
- Analytical Studies: No formal "adjudication" is described beyond reporting the direct visible results observed by "in-house operators."
- Clinical Accuracy Study: No multi-reader adjudication method (like 2+1 or 3+1) was used for the device's interpretation. The device's visual results were compared directly against the LC/MS/MS results. The "in-house operators" interpreted the results visually at five (5) minutes, and also at 15 minutes with identical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or described. This submission focuses on the standalone performance of the device relative to established analytical methods. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be provided.
6. Standalone Performance
Yes, extensive standalone performance was done. All studies described (analytical sensitivity, specificity, interference, and clinical accuracy) evaluate the algorithm's (in this case, the immunochromatographic test strip's visual output) performance without human-in-the-loop assistance in the sense of a diagnostic interpretation aid. The "in-house operators" merely read and recorded the visible bands, they were not "assisted" by an algorithm for diagnosis. The device itself is a standalone screening tool.
7. Type of Ground Truth Used
- Analytical Studies (Sensitivity, Specificity, Interference): Laboratory-prepared spiked samples with known concentrations of Buprenorphine and other substances.
- Clinical Accuracy Study: Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) results, which is a highly sensitive and specific confirmatory analytical method for drug detection.
8. Sample Size for the Training Set
The document does not describe explicit "training" of an algorithm in the modern sense of machine learning. For an immunochromatographic assay, the "training" (development and optimization) would involve experimental iterative refinements of the test strip components (antibodies, reagents, membrane) based on laboratory performance data. No specific sample size for such an iterative development process is provided, nor is it typically reported for this type of device. The reported studies represent the validation of the final device.
9. How the Ground Truth for the Training Set was Established
As noted above, no explicit "training set" with ground truth in the context of an algorithm or AI is described. The development of such a device relies on established chemical and immunological principles, with performance optimized through iterative laboratory testing using known concentrations of analytes and controls (similar to how the analytical studies were conducted for validation).
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OCT 1 8 2010
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: K100951
| Submitted By: | MEDTOX® Diagnostics, Inc. |
|---|---|
| 1238 Anthony Road | |
| Burlington, North Carolina 27215 |
- Phillip Hartzog, Ph.D. Contact Person: Director, Research & Development Phone: 336-226-6311, ext. 2863 Fax: 336-229-4471
Date Prepared: September 22, 2010
MEDTOX® Buprenorphine Test Proprietary Name:
Common Name: Buprenorphine test .
Classification Names: Buprenorphine test system
The applicant test system requlatory classification is Classification Panel is Clinical Toxicology (91) and Clinical Chemistry (75). Regulatory information applicable to the test system is provided below:
| CFR Section | Product Code |
|---|---|
| 862.3650, Opiate Test System (Buprenorphine) | C------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Acon BUP One Step Buprenorphine Test (K060466) Predicate Device:
Description of the Device
The MEDTOX® Buprenorphine Test is a rapid, single use, one-step qualitative immunochromatographic screening assay for the detection of Buprenorphine and its metabolites in human urine.
Intended Use
The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is intended for prescription use only. The MEDTOX Buprenorphine Test is not for over the-counter sale. It is not intended for use in point-ofcare settings.
MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations:
BUP Buprenorphine (Buprenorphine) 10 na/mL
The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result.
Discussion of Technological Characteristics:
Similarities and differences to predicate device
Both the MEDTOX® Buprenorphine Test and the predicate test are used to detect the presence of buprenorphine and its metabolites in human urine. In both systems, a urine sample is added to the test device and allowed to react for a specified period of time, after which the test device is read and interpreted visually. Both the MEDTOX® Buprenorphine Test and predicate test devices are rapid single micipiece viouslify: "Both the immunochromatographic lateral flow technology. Both the MEDTOX"
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Buprenorphine Test and predicate test devices utilize gold-conjugated reagents to generate the reddishpurple test and control lines, which are read visually.
Sample is applied to the MEDTOX® Burpenorphine Test by tilting a urine cup containing urine, while sample is applied to the predicate test by dipping the specified end of the urine sample. The MEDTOX® Burpenorphine Test has a read time window of 5 to 15 minutes, while the predicate test read time window is 5 to 10 minutes.
Overall characteristics of the MEDTOX® Buprenorphine Test and the predicate device are summarized in Table 1 below:
| Similarities | ||
|---|---|---|
| Item | Indications | Predicate, K060644 |
| Intended Use | Determines a preliminary qualitative positive or negativeresult for the presence of buprenorphine and its metabolitesin human urine. | Same |
| Cutoff | 10 ng/mL | Same |
| SystemProcedure | Sample is added to a single use test strip, which is then readvisually. | Same |
| MeasurementMethod | Visual | Same |
| Results | Provides preliminary negative, non-negative and invalidvisual test results. | Same |
| Differences | ||
| Item | Indications | Predicate, K060644 |
| Sampleapplication | Urine is applied to strip by tiltingurine cup | Strip is dipped into urine for a minimum of 5seconds |
| Assay Time | Test is read between 5 and 15minutes | Test is read between 5 and 10 minutes |
Table 1. Comparison of Similarities and Differences for the MEDTOX® Buprenorphine Test and the predicate device.
The following laboratory performance studies were conducted to determine the substantial equivalence of the MEDTOX® Buprenorphine Test to the predicate device. The studies included confirmation of the buprenorphine concentration by LC/MS/MS methods:
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence: The following Jaboratory performance studies were conducted to determine the substantial equivalence of the MEDTOX® Buprenorphine Test to the predicate:
Performance of the MEDTOX® Buprenorphine Test around the specific cutoff for Buprenorphine (10 ng/mL) was evaluated by testing standard drug solutions diluted in drug-free urine in triplicate on 5 different intervals by 3 in-house operators (45 determinations for each level). Drug free urine was also tested on each interval. The results were interpreted at 5 minutes and are summarized in Table 2 below:
| Table 2. Sensitivity/Precision/Distribution of Random Error | |||
|---|---|---|---|
| -- | -- | ------------------------------------------------------------- | -- |
| Buprenorphine (10 ng/mL) | ||||
|---|---|---|---|---|
| SampleConcentration(ng/mL) | % of Cutoff | Number ofObservations | # Neg | # Pos |
| 0 | Neg | 45 | 45 | 0 |
| 2.5 | 25% | 45 | 45 | 0 |
| 5.0 | 50% | 45 | 45 | 0 |
| 7.5 | 75% | 45 | 28 | 17 |
| 12.5 | 125% | 45 | 4 | 41 |
| 15.0 | 150% | 45 | 0 | 45 |
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Analytical specificity (cross reactivity and interference) data are summarized below.
Related Compounds and Cross Reactants
The metabolites and reacting compounds shown in Table 3 below were evaluated on the MEDTOX® Buprenorphine Test for interference or cross reactivity with Buprenorphine. Reference standards for the various metabolites and compounds were prepared in negative urine samples. Results are expressed as the approximate minimum concentration required to produce a positive result in the indicated assay. Compounds that reacted with the test are listed first, and related compounds that did not react with the highest concentration tested are listed second as Negative at 100,000 ng/mL (or highest level tested). The "% Cross-Reactive" values were calculated from the cut-off level for the calibrator used for each test (approximate 50% positive rate) divided by the lowest reported level found to react in the same test (greater than 66% positive rate). Three different lots were tested and identical results were obtained. The non-reacting opiate compounds were also tested following the study of M.L. Smith, et. al. Drug free urine samples were spiked with buprenorphine to the targeted concentrations of 5 ng/mL (50% of the cutoff) and 15 ng/mL (150% of the cutoff). 100 ug/mL of the non-reactive opiate compounds were then added to the preparation and assayed by MEDTOX Buprenorphine Test. Samples were evaluated in triplicate by in-house operators. None of the non-reactive opiate listed in the following table affected the expected results.
| Buprenorphine (BUP) (Buprenorphine, 10 ng/mL) | ||
|---|---|---|
| Compound | Result | % Cross-Reactive |
| Buprenorphine-glucuronide | Positive at 7.5 ng/mL | 133% |
| Norbuprenorphine | Positive at 50 ng/mL | 20% |
| Norbuprenorphine-glucuronide | Positive at 75 ng/mL | 13% |
| Codeine | Negative at 100,000 ng/mL | None Detected |
| Diacetylmorphine | Negative at 100,000 ng/mL | None Detected |
| Hydrocodone | Negative at 100,000 ng/mL | None Detected |
| Hydromorphone | Negative at 100,000 ng/mL | None Detected |
| Levorphanol | Negative at 50,000 ng/mL | None Detected |
| 6-MonoacetyImorphine | Negative at 100,000 ng/mL | None Detected |
| Morphine | Negative at 100,000 ng/mL | None Detected |
| Nalbuphine | Negative at 100,000 ng/mL | None Detected |
| Naloxone | Negative at 100,000 ng/mL | None Detected |
| Naltrexone | Negative at 100,000 ng/mL | None Detected |
| Norcodeine | Negative at 100,000 ng/mL | None Detected |
| Noroxycodone | Negative at 100,000 ng/mL | None Detected |
| Noroxymorphone | Negative at 100,000 ng/mL | None Detected |
| Oxycodone | Negative at 100,000 ng/mL | None Detected |
| Oxymorphone | Negative at 100,000 ng/mL | None Detected |
| Thebaine | Negative at 100,000 ng/mL | None Detected |
| Table 3. Related Compounds and Cross Reactants | |
|---|---|
| in the MEDTOX® Buprenorphine Test |
Interference Data
pH and Specific Gravity:
The MEDTOX® Buprenorphine Test was assayed with four negative clinical samples with pH values of 5.0. 6.0. 7.0, and 8.0 ± 0.1. Each sample was assayed in triplicate. The pH samples were fortified with buprenorphine to the concentrations of 5 ng/mL. All the pH levels gave negative results when fortified to 5 ng/mL, and all pH levels gave positive results when fortified to 15 ng/mL.
The MEDTOX® Buprenorphine test was assayed with three samples with specific gravity values of 1.003, 1.015 and 1.030 ± 0.001. Each sample was assayed in triplicate. The specific gravity samples were fortified with buprenorphine to the concentrations of 5 ng/mL. All the specific gravity levels gave negative results when fortified to 5 ng/mL, and all specific gravity levels gave positive results when fortified to 15 ng/mL.
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Non-Crossreactive Endogenous Compounds:
The endogenous compounds were tested following the study of M.L. Smith, et. al. 1 Drug free urine samples were spiked with buprenorphine to the targeted concentrations of 5 ng/mL (50% of the cutoff) and 15 ng/mL (150% of the cutoff). Most of the compounds were evaluated for interference of the MEDTOX Buprenorphine Test at 100 µg/mL (albumin was evaluated at 20 mg/mL and bilirubin was evaluated at 200 uq/mL). Samples were evaluated in triplicate by in-house operators. None of the endogenous compounds listed below affected the expected results.
Acetaldehyde -Acetone Albumin, Human Ascorbic acid Bilirubin Cholesterol
Creatinine Epinephrine ß-Estradiol Estriol Glucose Std. Solution Hemoglobin, Human
Sodium Chloride Tetrahydrocortisone d. 1-Thyroxine Uric Acid
Common Drugs:
Drug free urine samples were spiked with buprenorphine to the targeted concentrations of 5 ng/mL (50% of the cutoff) and 15 ng/mL (150% of the cutoff). 100 µg/mL of the common drugs were then added to the preparation and assayed by MEDTOX® Buprenorphine test. Samples were evaluated in triplicate by inhouse operators. None of the common drugs listed in the following table affected the expected results.
| Acetylsalicylic Acid | Chlorpheniramine | Ibuprofen |
|---|---|---|
| Acetaminophen | Cocaine | Morphine |
| Amitriptyline | Dextromethorphan | Phenobarbital |
| Brompheniramine maleate | Diphenylhydantoin | d-Pseudoephedrine |
| Caffeine | Doxylamine | Rifampin |
| Carbamazepine | Fluoxetine | Salicylic Acid |
| Vancomycin |
Table 4. Common Drugs Evaluated with the MEDTOX® Buprenorphine Test
Discussion of Clinical Tests Performed for Determination of Substantial Equivalence:
The accuracy of the MEDTOX® Buprenorphine Test was evaluated by assaying a panel of blind coded clinical urine samples containing varying concentrations of buprenorphine and its metabolites, and comparing the results with LC/MS/MS results. The samples were obtained from MEDTOX® Laboratories and are representative of intended population of clinical samples. Samples were screened with the CEDIA immunoassay system(Buprenorphine cutoff of 5ng/ml). Samples are stratified into the five following groups: (1) Negative samples were screened negative by CEDIA immunoassay system, 10% of which were confirmed negative by LC/MS/ (2) Near Cutoff Negative samples that fell between 50% of the cutoff concentration and the cutoff concentration; (3) Near Cutoff Positive samples that fell between the cutoff concentration and 150% of the cutoff concentration, and (4) High Positive samples that were greater than 150% of cutoff concentrations measured by LC/MS/MS included the testspecific analytes (buprenorphine and norbuprenorphine) found in the sample. The testing was performed by in-house operators according to the package insert. The results were interpreted visually at five (5) minutes. No false positives were observed in the absence of drug. The tests were read at both 5 minutes and 15 minutes and identical results were obtained. The results are summarized in Table 5 below.
| DRUG | MEDTOX®BuprenorphineTest | NoDrug | NearCutoffNegative(between-50% andcutoff) | NearCutoffPositive(Betweencutoff and+50%) | HighPositive(greaterthan+50%) | %Agreement |
|---|---|---|---|---|---|---|
| BUP(10 ng/mL) | Positive | 0 | 3 | 8 | 72 | 100% |
| Negative | 70 | 4 | 0 | 0 | 96.1% |
Table 5. MEDTOX® Buprenorphine Test vs Stratified LC/MS/MS Values
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For samples giving preliminary positive results below the cutoff, the assayed values are detailed in Table 6 below:
| MEDTOX® BuprenorphineTest (10 ng/mL) | LC/MS/MS Value (Drug or Metabolite, ng/mL) |
|---|---|
| positive | total buprenorphine at 5 ng/mL |
| positive | total buprenorphine at 7 ng/mL |
| positive | total buprenorphine at 9 ng/mL |
Table 6. ACCURACY/SUMMARY of DISCORDANT RESULTS
Conclusions:
The MEDTOX® Buprenorphine Test has the same intended use and similar technological characteristics as the predicate device. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new issues of safety or effectiveness. Thus, the MEDTOX® Buprenorphine Test is substantially equivalent to the predicate device.
Reference
- Smith, M.L., Shimomura, E.T., Summers, J., Paul, B.D., Nichols, D., Shippee, R., Jenkins, A.J., Darwin, W.D., and Cone, E.J. Detection Times and Analytical Performance of Commercial Urine Opiate Immunoassays Following Heroin Administration, Journal of Analytical Toxicology, Volume 24:7. October 2000, pages 522-529.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Medtox Diagnostics Inc. c/o Phillip Hartzog Director, Research and Development 1238 Anthony Road Burlington, NC 27215
Food & Drug Administration 10903 New Hampshire Avenue Buildina 66 Silver Spring, MD 20993
OCT 1 8 2010
K100951 Re: Trade Name: Medtox Buprenorphine Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: DJG Dated: September 23, 2010 Received: September 24, 2010
Dear Dr. Hartzog:
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 the Federal Food, Drag, und Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confrom provisions or 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 IT your device is classinod (oos as of official controls. Existing major regulations affecting (FMA), it may be subject to such acultions of Federal Regulations (CFR), Parts 800 to 895. your device can be found in This 21, Oncornerents concerning your device in the Eederal 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 mean that FDA has made a decemination that your administered by other Federal gencies.
Of the Act or any Federal statutes and regulations administered by other to registress of the Act of ally rederal statutes and regarements, including, but not limited to: registration Tourings .compty with an the rise rever state (21 CFR Parts 801 and 809); medical device a and listing (21 CFR Fall 007), laboring (21 CFR 803); and good reporting (reporting of medical device reat forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K100951
_OCT 1 8 2010
Device Name: MEDTOX® Buprenorphine Test
Indication For Use:
The MEDTOX Buprenorphine Test uses immunochromatographic test strips for the rapid, qualitative detection of buprenorphine and its metabolites in human urine. It is intended for prescription use only. The MEDTOX Buprenorphine Test is not for overthe-counter sale. It is not intended for use in point-of-care settings.
MEDTOX Buprenorphine detects buprenorphine and its metabolites at the following cutoff concentrations:
Buprenorphine (Buprenorphine) BUP 10 ng/mL
The MEDTOX Buprenorphine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature of Offeror
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
1/00951
Page 1 of 1
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).