(28 days)
No
The device description and intended use clearly indicate a lateral flow immunoassay with visual interpretation, which does not involve AI/ML.
No.
This device is for qualitative detection of multiple drugs and drug metabolites in human urine, providing only a preliminary result for diagnostic purposes, not for treating or preventing disease.
Yes
Explanation: The device is an "immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine." This directly aligns with the definition of a diagnostic device, which is used to detect or identify a disease or medical condition.
No
The device is a lateral flow immunoassay, which is a physical test strip that requires a urine sample and provides a visual result. This is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative detection of multiple drugs and drug metabolites in human urine." This involves testing a biological sample (urine) in vitro (outside the body) to gain information about a person's health status (presence of drugs).
- Device Description: The description further clarifies it's a "lateral flow immunoassay" used for the "qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens." This reinforces the in vitro nature of the testing.
- Sample Type: The device uses human urine, which is a biological specimen.
- Purpose: The purpose is to detect the presence of drugs and drug metabolites, which is a diagnostic or screening function.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
| Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|
| AMP | d-Amphetamine | 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC 150 | Benzoylecgonine | 150 |
| COC | Benzoylecgonine | 300 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 |
| MET 500 | d-Methamphetamine | 500 |
| MET | d-Methamphetamine | 1000 |
| MTD | dl-Methadone | 300 |
| OPI 300 | Morphine | 300 |
| OPI | Morphine | 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-A9-THC-9-COOH | 50 |
The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN, LAF
Device Description
The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in three formats that use identical test strips: Dipcard, Cassette, and Cup. The modified device contains up to seventeen (17) assays that can include up to thirteen (13) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Simplified performance studies were conducted to demonstrate that the sensitivity, precision, and specificity of the modified device was unchanged from the predicate devices. The analytical performance verification testing confirms that the Ameditech ImmuTest Multi-Drug Screen has equivalent performance compared with the predicate devices in terms of precision (reproducibility), analytical specificity, analytical specificity, and interfering substances.
No clinical studies were conducted as both the modified and predicate devices use identical test strips, and the performance characteristics validated in the predicate submissions are applicable to the modified device.
Conclusion: Performance verification and validation studies have demonstrated that the device is as safe, as effective, and performs as well or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity, precision, and specificity
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
NOV 10 2011
NIRS
Total Multi-Purpose Sensor
ImmuTest Multi-Drug Sc
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 and follows the Device Advice Guidance concerning "How To Prepare A Special 510(k)"
Submitter: A.
| Submitter: | Ameditech, Inc.
10340 Camino Santa Fe.
San Diego, CA 92121 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Greg Cerra
Senior Manager, Regulatory Affair
Phone: 858.805.3036
Fax: 858.805.7100
Email: gregory.cerra@alere.com |
| Date prepared: | October 12, 2011 |
Device Names: B.
Ameditech ImmuTest Multi-Drug Screen Dipcard Ameditech ImmuTest Multi-Drug Screen Cassette Ameditech ImmuTest Multi-Drug Screen Cup
Predicates:
Ameditech ImmuTest Multi-Drug Screen Panel III (K050186)
C. Device Description:
The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in three formats that use identical test strips: Dipcard, Cassette, and Cup. The modified device contains up to seventeen (17) assays that can include up to thirteen (13) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.
1
D. Intended Use:
The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
| Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|
| AMP | d-Amphetamine | 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC 150 | Benzoylecgonine | 150 |
| COC | Benzoylecgonine | 300 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 |
| MET 500 | d-Methamphetamine | 500 |
| MET | d-Methamphetamine | 1000 |
| MTD | dl-Methadone | 300 |
| OPI 300 | Morphine | 300 |
| OPI | Morphine | 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-A9-THC-9-COOH | 50 |
The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
Comparison with the Predicate ن
The modified device is identical to the cleared predicates referenced above (K050186). The drug strips cleared by FDA in submissions K040092, K042975, and K063015 will be consolidated into a single device. The purpose of this submission is to cover all the drug strips and their respective cutoffs with a single 510(k) clearance. See Section 12.2 of this submission for a detailed comparison of the modified device with the predicates.
2
F. Nonclinical Data:
As the test strips in both the modified and predicate devices are identical in terms of intended use, test principle, manufacturing process, and raw materials; simplified performance studies were conducted to demonstrate that the sensitivity, precision, and specificity of the modified device was unchanged from the predicate devices. The analytical performance verification testing confirms that the Ameditech ImmuTest Multi-Drug Screen has equivalent performance compared with the predicate devices in terms of precision (reproducibility), analytical specificity, analytical specificity, and interfering substances.
G. Clinical Data:
Both the modified and predicate devices use identical test strips, therefore we did not conduct any clinical studies for this special 510(k) submission, because the performance characteristics that were validated in the predicate submissions are applicable to the modified device.
H. Conclusions Drawn from Testing Results:
Performance verification and validation studies have demonstrated that the device is as safe, as effective, and performs as well or better than the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing or protecting another figure, which is a common symbol associated with the department.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ameditech, Inc. c/o Mr. Greg Cerra Senior Manager, Regulatory Affairs 10340 Camino Santa FE, Suite F San Diego, California 92121
NOV 1 0 2011
Re: K113046 Trade Name: Ameditech Immutest Milti-Drug Screen . Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system. Regulatory Class II Product Codes: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN, LAF Dated: October 13, 2011 Received: October 13, 2011
Dear Mr. Cerra:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR Part 80% 97%. For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding of any 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/de('ault.htm.
Sincerely yours.
z
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Ameditech, Inc.
Indications for Use Statement
510(k) Number (if known):
Device Name: ImmuTest Multi-Drug Screen
Indications for Use:
The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
| Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|
| AMP | d-Amphetamine | 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC 150 | Benzoylecgonine | 150 |
| COC | Benzoylecgonine | 300 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 |
| MET 500 | d-Methamphetamine | 500 |
| MET | d-Methamphetamine | 1000 |
| MTD | dl-Methadone | 300 |
| OPI 300 | Morphine | 300 |
| OPI | Morphine | 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-A9-THC-9-COOH | 50 |
The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs isted above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
Prescription Use______________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801, Subpart D) AND/OR
Over-the-Counter Use (Part 21 CFR 807, Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruth Chalon
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k):
Page 1 of 1