(55 days)
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Methamphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Amphetamine, Phencyclidine, Notriptyline and Methadone, Methylenedioxymethamphetamine, Morphine, Oxycodone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Methamphetamine, Cannabinoids, Oxazepam, Cocaine, Amphetamine, Secobarbital, Notriptyline and Methadone, Phencyclidine, Methylenedioxymethamphetamine, Morphine, Oxycodone in human urine samples. Wondfo Multi-Drug devices detect each of analytes on different strips.
A positive urine sample will not generate a colored line for the specific drug tested in the designation of third. Creating region. A negative urine specimen or a urine sample containing Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone below the cutoff levels will produce a colored line in the test region for the drug. To serve as a test control, a color line will always appear at the control region.
The provided text describes an in vitro diagnostic device (Wondfo Multi-Drug Urine Test Cup and Panel) for drug screening. As such, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (e.g., performance metrics like sensitivity/specificity, sample sizes for test sets, expert ground truth, MRMC studies) are not applicable.
This device is a qualitative immunoassay for the simultaneous detection of various drugs in human urine. The "acceptance criteria" here refer to the device's ability to accurately detect the presence or absence of specific drugs at defined cutoff concentrations. The "study" would involve testing the device's performance against known positive and negative urine samples.
Based on the provided document, here's a breakdown of the requested information, adapted for this type of device:
Acceptance Criteria and Device Performance for Wondfo Multi-Drug Urine Test Cup and Panel
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily based on its ability to correctly identify positive and negative samples relative to established cutoff concentrations. While a detailed performance table from a specific study is not provided in the summary, the "Intended Use" section defines the critical cutoff levels for each drug. The "Description of the device" further details the expected visual results for positive and negative samples, which form the basis of performance evaluation during validation.
| Drug (Identifier) | Cut-off Level (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/mL | (Not specified in document) |
| Secobarbital (BAR) | 300 ng/mL | (Not specified in document) |
| Oxazepam (BZO) | 300 ng/mL | (Not specified in document) |
| Cocaine (COC) | 300 ng/mL | (Not specified in document) |
| Cannabinoids (THC) | 50 ng/mL | (Not specified in document) |
| Methamphetamine (MET) | 1000 ng/mL | (Not specified in document) |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | (Not specified in document) |
| Morphine (MOP) | 300 ng/mL | (Not specified in document) |
| Methadone (MTD) | 300 ng/mL | (Not specified in document) |
| Phencyclidine (PCP) | 25 ng/mL | (Not specified in document) |
| Notriptyline (TCA) | 1000 ng/mL | (Not specified in document) |
| Oxycodone (OXY) | 100 ng/mL | (Not specified in document) |
Note: The document states "Wondfo Multi-Drug devices detect each of analytes on different strips" and describes how positive/negative samples are indicated visually. The regulatory submission implies that the device successfully meets performance requirements for detecting these substances at the specified cut-off levels, but the specific performance metrics (e.g., sensitivity, specificity, accuracy, precision data) from the validation studies are not included in this summary. These would typically be found in the full 510(k) submission.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not include details on the specific sample sizes used for the validation or test sets. Similarly, data provenance (e.g., country of origin of data, retrospective or prospective) for the performance evaluation is not specified. For in vitro diagnostics, performance studies typically involve testing a statistically significant number of known positive and negative urine samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For an in vitro diagnostic device like this, the "ground truth" is established through highly accurate analytical methods in a laboratory setting, rather than through expert human interpretation of images.
- Ground Truth Establishment: The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) would be used to objectively determine the true presence and concentration of drugs in urine samples, serving as the gold standard.
- Experts: The "experts" involved would be highly skilled analytical chemists or laboratory professionals proficient in operating and interpreting results from GC/MS or LC/MS systems. The number and specific qualifications are not mentioned in this summary.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense. The "adjudication" for an immunoassay largely relies on the objective results from the confirmatory chemical methods (GC/MS or LC/MS) rather than a consensus among human reviewers. Discrepancies between the immunoassay and the confirmatory method would be analyzed to understand the immunoassay's performance characteristics (e.g., false positives/negatives).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are typically used to assess algorithmic performance in interpretation tasks that traditionally involve human readers (e.g., radiology, pathology). This device is a biochemical assay for drug detection, not an interpretive algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device operates as a standalone diagnostic test. Humans are involved in applying the sample and visually reading the result (presence/absence of a line), but the core detection mechanism is an immunoassay, not an AI algorithm. The performance evaluation would inherently be "standalone" in the sense of the immunoassay itself, without requiring human "interpretation" beyond reading the literal presence or absence of a line.
7. The Type of Ground Truth Used
The ground truth used for validating this device would be definitive analytical testing, specifically GC/MS or LC/MS, as stated in the intended use: "GC/MS or LC/MS is the preferred confirmatory method."
8. The Sample Size for the Training Set
Not applicable in the context of an immunoassay. Immunoassays are not "trained" in the way AI/ML algorithms are. Their performance is inherent to their biochemical design (antibodies, reagents, flow characteristics). Therefore, there is no "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
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NOV 1 5 2012
SIO(K)SUMMARY
-
Date the summary was prepared:
-
Submitter's name: Address:
Phone:
Name of contact person:
October 22, 2012 Guangzhou Wondfo Biotech Co., Ltd.
South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069 Joe Shia
LS! International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20877 Telephone: 240-505-7880 Fax: 301-916-6213
- Name of the device
| Common or usual name: | Multi-Drug Urine Test CupMulti-Drug Urine Test Panel |
|---|---|
| Trade or proprietary name: | Wondfo Multi-Drug Urine Test CupWondfo Multi-Drug Urine Test Panel |
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | Classification | Regulation Section | Panel. |
|---|---|---|---|
| DKZ | II | 21 CFR § 862.3100, AmphetamineTest System | Toxicology(91) |
| LDJ | II | 21 CFR § 862.3870, CannabinoidsTest System | Toxicology(91) |
| DIO | II | 21 CFR § 862.3250, Cocaine andCocaine Metabolites Test System | Toxicology(91) |
| LAF | II | 21 CFR § 862.3610,Methamphetamine Test System | Toxicology(91) |
| DJR | II | 21 CFR § 862.3620, MethadoneTest System | Toxicology(91) |
| LAF | II | 21 CFR § 862.3610,Methylenedioxymethamphetamine Test System | Toxicology(91) |
| DJG | II | 21 CFR § 862.3650, MorphineTest System | Toxicology(91) |
| LFG | II | 21 CFR § 862.3910, Tricyclicantidepressant drug test system | Toxicology(91) |
| JXM | II | 21 CFR § 862.3170,Benzodiazepine Test System | Toxicology(91) |
| DJG | II | 21 CFR § 862.3650, Opiate TestSystem | Toxicology(91) |
| LCM | unclassified | Enzyme ImmunoassayPhencyclidine | Toxicology(91) |
| DIS | II | 21 CFR § 862.3150, BarbiturateTest System | Toxicology(91) |
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4. Description of the device:
Wondfo Multi-Drug Urlne Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, Worldlo Mont-Drug Online Test Out and Vient Cualitative and simultaneous detection of Methamphetamine, Cannabinolds, Oxazepam, Cocaine, Amphetamine, Secobarbital, Notriptyline and Methadone, Phencyclidine, Mothylenedloxymethamphetamine, Morphine, Mathylenedioxymenamples. Wondfo Multi-Drug devices detect each of analytes on different strips.
A positive urine sample will not generate a colored line for the specific drug tested in the designation of third. Creating region. A negative urine specimento a estomole containing Amphetamine, Secobarbital, Oxazepam,
region. A negative urine specimen or a urine sample containing, Mornhino, Mothe region. A negativ anno upetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Cocame, Califianninoids, Medianine, Methylononymenting warmer outoff levels will Prilence, Noulptyine and Oxybedile t.region for the drug. To serve as a test control, a color line will always appear at the control region.
5. Intended use of the device:
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, Wonds How immunochromatographic assays for qualitative and simultaneous detection of Methamphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Amphetamine, Phencyclidine, Notriptyline and Methadone, Methylenedioxymethamphetamine, Morphine, Oxycodone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be The use provides only premimary cover seen . GCMS or LCMS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription druge Nortriptyline, dasses. Clinial The test will yield prominary politive rested, even at or above therapeutic doses. Clicical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
6. Comparison to the predicate device
o. Comparison to the predicate device
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are a "modified" profuct forma of Wolfied from the previously FDA-cleared Wondfo single DOA Tests. A summary comparison of features of derived from the previously FDA-Geared Worldfo Multi-Drug Urine Test Panel and the prodicate devices is provided In the following Table
| Item | New Devices | Predicate devices (K112071) |
|---|---|---|
| Indication(s) for use | For the qualitative determination of Amphetamine (AMP), Secobarbital (BAR), Oxazepam (BZO), Cocaine (COC), Cannabinoids (THC), Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA) | For the qualitative determination of Cocaine (COC), or Methamphetamine (MET), in human urine.The configurations of the Predicate devices are |
{2}------------------------------------------------
| Morphine (MOP), Methadone (MTD),Phencyclidine (PCP), Notriptyline (TCA), and/orOxycodone(OXY) in human urine.The configurations of the New Devices areavailable in any combination of the above tests. | only available in single drug test. | |
|---|---|---|
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibody immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive ornegative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/mlSecobarbital(BAR): 300 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/mlCannabinoids (THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMethylenedioxymethamphetamine (MDMA): 500ng/mlMorphine (MOP): 300 ng/mlMethadone (MTD): 300 ng/mlPhencyclidine (PCP): 25 ng/mlNotriptyline (TCA): 1,000 ng/mlOxycodone(OXY): 100 ng/ml | Same |
| Configurations | Cup, dip card | Same |
| Intended Use | OTC Use & Prescription Use | Same |
ﺗﻢ ﺍﻟﻤﺮﺍﺟﻊ
Wondfo Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 12 drug Llrino Wondo Multi-Drug Office fest Oupla a multi artist and the Wondfo Multi-Drug Unine
of abuse tests while the predicate devices are single-drug the state the Wondfo Test Panel is the same as the test dip card format of the predicate devices except that the Wondfo Test Panel is the test Panel is a multi-drug test that offers any combination from 2 to 12:44
Multi-Drug Urine Test Panel ls a multi-drug test that offers any combination fro
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 15, 2012
Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878
Re: K122904
Trade/Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel Regulation Number: 21 CFR § 862.3250 Regulation Name: Cocaine and cocaine metabolite test system. Regulatory Class: Class II Product Code: DIO, DKZ, LDJ, LAF, DJR, DJG, LFG, JXM, LCM, DIS Dated: October 22, 2012 Received: October 25, 2012
Dear Mr. Shia:
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 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); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set
{4}------------------------------------------------
Page 2 - Joe Shia
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.
If vou desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson
for
Courtney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K122904
Device Name: Wondfo Multi-Drug Urine Test Cup
Indications for Use:
Urine Test Cup is competitive binding, lateral flow Wondfo Multi-Drug detection for qualitative and simultaneous of immunochromatographic assay Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Husca-Libs
Division Sign Off
Division Sign-0 Office of In Vitro Diagnostics and Radiological Health
510(k) KL22904
{6}------------------------------------------------
The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X . (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 Diagnostics and Radiological Health (OIR)
Denise Johnson-Lyles
Division Sign Off
ivision Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K22904
{7}------------------------------------------------
Indications for Use
510(k) Number (if known): K122904
Device Name: Wondfo Multi-Drug Urine Test Panel
Indications for Use:
Urine Test Panel is competitive binding, lateral flow Wondfo Multi-Drug immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Ohunmgle
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122904
{8}------------------------------------------------
The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (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 Diagnostics and Radiological Health (OIR)
Denise Annon-Cyles
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122904
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).