(10 days)
No
The device description and performance studies indicate a lateral flow immunoassay with visual interpretation, with no mention of AI or ML.
No.
This device is an immunoassay for the qualitative detection of drugs and drug metabolites in human urine. It is used for diagnostic purposes (detection of substances) rather than for treating or mitigating a disease or condition.
Yes
The device is described as an "immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine," which is used to provide a "preliminary result" for diagnostic purposes. It identifies the presence of substances that may indicate a condition (drug use), fitting the definition of a diagnostic device.
No
The device description clearly states it is a lateral flow immunoassay with physical test strips and cups for urine collection and analysis, which are hardware components.
Based on the provided information, the CHECKCUP™ Multi-Drug Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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 diagnostic information about the presence of substances.
- Device Description: The device description further clarifies it's a "lateral flow immunoassay intended for professional (prescription) use only" and is 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 test and its purpose in analyzing a biological sample.
- Regulatory Context: The mention of predicate devices with K numbers (K053175 and K113046) strongly suggests that this device is being submitted for regulatory clearance as a medical device, specifically an IVD, as these K numbers are associated with FDA 510(k) submissions for medical devices, including IVDs.
Therefore, the CHECKCUP™ Multi-Drug Test fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CHECKCUP™ Multi-Drug Test 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-Δ9-THC-9-COOH | 50 |
The CHECKCUP™ Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ 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, DIO, DJC, DJR, DJG, LCM, JXN, LFG
Device Description
The Ameditech CHECKCUP™ Multi-Drug Test 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 two formats that use identical test strips: Round Cup and Flat Cup. The modified device contains up to seventeen (17) assays that include fourteen (14) 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional (prescription) 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 study approach was based on previous similar submission (K113046). The analytical performance verification and validation testing confirms that the Ameditech CHECKCUP™ has equivalent performance compared with the predicate devices in terms of precision (reproducibility), analytical sensitivity, analytical specificity, and interfering substances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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
Ameditech, Inc.
DEC - 5 2011 K. 113
CHECKCUP™ Multi-Drug Test
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)"
A. Submitter:
| Submitter: | Ameditech, Inc.
10340 Camino Santa Fe.
San Diego, CA 92121 |
|-----------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brett Casey
General Manager
Phone: 858-805-3603
Fax: 858-535-1838
Email: brett.casey@alere.com |
| Date prepared: | 11/22/2011 |
Date prepared:
B. Device Name:
Ameditech CHECKCUP™
Predicates:
Ameditech DrugSmart Cup (K053175)
C. Device Description:
The Ameditech CHECKCUP™ Multi-Drug Test 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 two formats that use identical test strips: Round Cup and Flat Cup. The modified device contains up to seventeen (17) assays that include fourteen (14) 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 CHECKCUP™ Multi-Drug Test 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 CHECKCUP™ Multi-Drug Test consists of two test formats: round cup and flat cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ Multi-Drug Test 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.
2
510(k) Summary
CHECKCUP™ Multi-Drug Test
Comparison with the Predicate
The modified device is identical to the cleared predicate referenced above (K053175). The drug strips cleared by FDA in submission K113046 will be placed in round cup that was cleared in K053175. In addition, the drug strips will be placed in a new format (flat cup).
The CHECKCUP™ Multi-Drug Test is a device modification of the previously 510(k) cleared Ameditech DrugSmart Cup (K053175). The CHECKCUP™ Multi-Drug Test expands the current drug test menu of the Ameditech DrugSmart Cup by adding the drug test strips cleared in K113046. The CHECKCUP™ Multi-Drug Test has two formats: round cup and flat cup. The CHECKCUP™ round cup is exactly the same cup as in the Drugsmart Cup. Both CHECKCUP™ round cup and DrugSmart Cup consist of multiple 1-drug strips. The plastic strip holder in the CHECKCUP™ flat and DrugSmart Cup are both flat except in the DrugSmart Cup, the plastic strip holder is a malleable piece of plastic that gets curved when inserted into the DrugSmart Cup. The CHECKCUP™ flat cup plastic strip holder stays flat when inserted into the CHECKCUP flat cup. The CHECKCUP™ flat cup consist of 1-drug/strip tests or 2-drug/strip tests or a mixture of both. Below is an illustration of DrugSmart Cup and CHECKCUP™ Multi-Drug Test (round and flat format). The modified and 510(k) cleared devices are identical in terms of intended use, principle, test strip manufacturing process and raw material used. The modified device detects 17 drug tests versus these drug tests are detected in separate devices K053175 and K113046. The purpose of this submission is to cover all the drug strips and their respective cutoffs with a single device. See Section 12.2 of this submission for a detailed comparison of the modified device with the predicates.
Image /page/2/Figure/6 description: The image shows three different drug testing cups. The first cup is labeled "DrugSmart Cup" and is described as "Unmodified". The text below the cup states that it detects up to 13 drugs with 1 strip per drug. The other two cups are labeled "CHECKCUP (round version)" and "CHECKCUP (flat version)" and are described as "Check Cup Multi Drug Test", detecting up to 17 drugs with 1 strip/drug, 2 strip/drug (flat cup) or both (flat cup).
3
510(k) Summary
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 study approach was based on previous similar submission (K113046). The analytical performance verification and validation testing confirms that the Ameditech CHECKCUP™ has equivalent performance compared with the predicate devices in terms of precision (reproducibility), analytical sensitivity, analytical specificity, and interfering substances. Refer to Appendix D- Testing Strategy. .. .
E. 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.
F. 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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
10903 New Hampshire Avenue Silver Spring, MD 20993
AMEDITECH. INC C/O Brett Casey 10340 Camino Santa Fe. Suite F San Diego, CA 92121
DEC - 5 2011
Re: K113501
Trade Name: Ameditech CHECKCUP™ Multi-Drug Test Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Codes: DKZ, DIS, JXM, DIO, DJC, DJR, DJG, LCM, JXN. LFG Dated: November 25, 2011 Received: November 25, 2011
Dear Mr. Casey:
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).
5
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 note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/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/default.htm
Sincerely yours.
N
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Ameditech, Inc.
Indications for Use Statement
510(k) Number (if known): K || 350 |
Device Name: CHECKCUP™ Multi-Drug Test
Indications for Use:
The CHECKCUP™ Multi-Drug Test 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-Δ9-THC-9-COOH | 50 |
The CHECKCUP™ Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ 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 X (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)
ARS
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k): K113501
Page 1 of 1