(68 days)
No
The device description and intended use clearly describe a visually read immunoassay test. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The results are determined by the presence or absence of a colored band, which is a manual interpretation.
No
The device is an in-vitro diagnostic test for detecting substances of abuse in urine, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine." This qualifies it as a diagnostic device because it detects substances relevant to a medical or behavioral condition.
No
The device description clearly outlines a physical, single-use cassette device with a membrane strip, plastic housing, and a disposable dropper. It is an in-vitro diagnostic test that relies on a chemical reaction and visual interpretation, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "This assay is intended for Professional and Laboratory In-Vitro Use Only." This is a clear indicator of an IVD.
- Device Description: The description details a test that analyzes a biological sample (human urine) in vitro (outside the body) to detect specific substances (drugs and their metabolites).
- Mechanism: The device uses an immunoassay, which is a common technique used in IVD tests to detect the presence or absence of specific molecules in a sample.
- Performance Studies: The document mentions "Analytical Performance" and "Comparison Studies to Predicates," which are typical performance evaluations conducted for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The listed predicate devices are also IVD drug screening tests.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nano-Check™ DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, Methamphetamine and Phencyclidine is a rapid, self-controlled immunoassay for the qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine. The detection limits (cut-off concentrations) of this test are as follows: Cannabinoids at 50 ng/ml, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.
Product codes
LDJ, DIO, DJC, DJG, LCM
Device Description
The Nano-Check™ DAT 5M test is a one step, type II, competitive immuochromatographic assay for the qualitative detection of Cannabinoid, Opiate, Benzoylecgonine, Methamphetamine and Phencyclidine compounds and their metabolites in human urine. The Nano-Check™ DAT 5M test device contains a membrane strip on which either antibodies against drug or drug conjugate to protein are immobilized at each specific test line. The colored indicator antibody or antigen coupled with Gold colloidal particles is place at the end of membrane.
The test is a single-use visually read cassette device in a plastic housing. It contains the test strip containing 5 test lines and 1 control line. Urine sample can be dropped onto sample well using plastic disposable dropper, which is provided. Drug positive urines will not show a colored band, while drug negative urine sample or urine sample containing drugs below cutoff level will generate red colored band.
The device is sealed in a pouch desiccant and provided with instructions for use and a disposable sample dropper.
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 and Laboratory In-Vitro 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)
Non-Clinical Tests:
- a. Analytical Performance
- Precision/Reproducibility .
- Traceability, stability, expected values .
- Detection Limit .
- Analytical Specificity .
- Assay Cut-off .
- b. Comparison Studies to Predicates
- . Method Comparison with Predicate Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003557, K040274, K010841, K011672, K011730
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
MAY 2 5 2005
EXHIBIT #1
510(K) SUMMARY
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:_KOS 0594
1. Submitter's Identification:
Nano-Ditech Co. 11 Deer Park Dr., Suite 118 Monmouth Junction, NJ 08852 Tel: 732-438-8616 Fax: 732-438-8617
Contact: Anand Akerkar, Ph.D.
Date Summary Prepared: March 7, 2005
2. Name of the Device:
Nano-Check™ DAT 5 Multi Drug Screening Test for Cannabinoids (THC), Opiates, (OPI), Cocaine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP)
Also known as: The Nano-Check™ DAT 5M Test
Common or Usual Name:
Rapid, One-Step Qualitative Immuno-Chromatographic Assay for Multi Panel Drug of Abuse Test
3. Predicate Device Information:
-
ACON THC One Step Marijuana Test Strip, ACON Laboratories, Inc., San Diego, CA, K003557
-
ACON OPI One Step Opiates Test Strip, ACON Laboratories, Inc., San Diego, CA, K040274
-
ACON COC One Step Cocaine Test Strip, ACON Laboratories, Inc., San Diego, CA, K010841
1
-
ACON mAMP One Step Methamphetamine Test Strip, ACON Laboratories, Inc., San Diego, CA, K011672
-
ACON PCP One Step Phencyclidine Test Strip, ACON Laboratories, Inc., San Diego, CA, K011730
Device Description: 4.
The Nano-Check™ DAT 5M test is a one step, type II, competitive immuochromatographic assay for the qualitative detection of Cannabinoid, Opiate, Benzoylecgonine, Methamphetamine and Phencyclidine compounds and their metabolites in human urine. The Nano-Check™ DAT 5M test device contains a membrane strip on which either antibodies against drug or drug conjugate to protein are immobilized at each specific test line. The colored indicator antibody or antigen coupled with Gold colloidal particles is place at the end of membrane.
The test is a single-use visually read cassette device in a plastic housing. It contains the test strip containing 5 test lines and 1 control line. Urine sample can be dropped onto sample well using plastic disposable dropper, which is provided. Drug positive urines will not show a colored band, while drug negative urine sample or urine sample containing drugs below cutoff level will generate red colored band.
The device is sealed in a pouch desiccant and provided with instructions for use and a disposable sample dropper.
Test Principle:
The Nano-Check™ DAT 5M test is a one step, type II, competitive immuochromatographic assay for the qualitative detection of Cannabinoid, Opiate. Benzoylecgonine, Methamphetamine and Phencyclidine compounds and their metabolites in human urine. The Nano-Check ™ DAT 5M test device contains a membrane strip on which either antibodies aqainst drug or drug coniugate to protein are immobilized at each specific test line. The colored indicator antibody or antigen coupled with Gold colloidal particles is place at the end of membrane.
When the test urine is applied on to the sample well of the device, the colored indicator particles move along with sample urine across membrane by the capillary action. If any of specified drugs in urine specimen, it competes with either colored indicator drug conjugate or drug antibodies for the limited amount antibodies or drug conjugates immobilized on the membrane. If equal or more than cut off concentration of drug or its metabolite is present in the sample urine,
2
the drug compounds will prevent the binding of drug conjugate to the target antibody. Thus positive drug urines will not show a colored band at the indicted drug test line on the membrane. Absence of colored band at a specific drug line indicated positive results, while the presence of colored band indicated a negative result for the specific drug. The is present in the test window for self-procedure validation control. This colored control band always appears at the control line position (CON) in the valid test results. Any test results is not valid if the control line does not appear in the test window.
5. Intended Use:
The Nano-Check™ DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, Methamphetamine and Phencyclidine is a rapid, self-controlled immunoassay for the qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine. The detection limits (cut-off concentrations) of this test are as follows: Cannabinoids at 50 ng/ml, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.
6. Comparison to Predicate Devices:
Overall performance and characteristics of the Nano-Check™ DAT 5M Test compared to the predicate devices (cited below), are summarized in the table below:
| Item | Device | Predicates | ||||
|---|---|---|---|---|---|---|
| THC | ||||||
| Marijuana test strip | OPI | |||||
| Opiate test strip | COC | |||||
| Cocaine test strip | mAMP | |||||
| methamphetamine test strip | PCP | |||||
| Phencyclidine test strip | ||||||
| Similarities | ||||||
| Test Principle | Immunochromatographic, | |||||
| lateral-flow, competitive | ||||||
| assay | Same | |||||
| Type of test | Qualitative | Same | ||||
| Assay time | 10 min | Same | ||||
| Sample type | Human urine | Same | ||||
| Intended use | Professional use | Same | ||||
| Cutoff | THC:50ng/ml | Same |
COMPARISON TABLE
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| concentration | OPI:2000 ng/ml | |
|---|---|---|
| COC:300 ng/ml | ||
| mAMP:1000 ng/ml | ||
| PCP: 25 ng/ml | ||
| Differences | ||
| # test /strip | Multiple (5 tests / strip) | Single (1 test/strip) |
| Sample | ||
| application | Transfer urine specimen | |
| with disposable pipette | Immerse the test strip in the urine specimen |
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following performance characteristics were addressed to support this submission.
- a. Analytical Performance
- Precision/Reproducibility .
- Traceability, stability, expected values .
- Detection Limit .
- Analytical Specificity .
- Assay Cut-off .
- b. Comparison Studies to Predicates
- . Method Comparison with Predicate Devices
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
The submitted data for this premarket notification support a substantial equivalence decision for the Nano-Check™ DAT 5 Multi Drug Screening Test THC/OPI/COC/mAMP/PCP in comparison to the ACON One Step Single Test Strips, K003557, K040274, K010841, K011672, and K011730.
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Image /page/4/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 representation of a human figure, composed of three curved lines that suggest a person in motion or reaching out.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2005
Nano-Ditech Co. c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd Suite 200 Great Neck, NY 11021
K050594 Re:
Trade/Device Name: Nano- Check™ DAT 5 Multi Drug Screening Test for Cannabinoids (THC), Opiates (OPI), Cocaine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO, DJC, DJG, LCM Dated: March 7, 2005 Received: March 8, 2005
Dear Ms. Goldstein-Falk:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon you to ought indiag of substantial equivalence of your device to a legally promative netirete device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K050594 510(k) Number:
Nano-Check™ DAT 5 Multi Drug Screening Test for Cannabinoids Device Name: Device Name: Namo Chesine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP)
Indications For Use:
The Nano-Check™ DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, The Nano-Oncok - BATP o main Lirine is a rapid, self-controlled immunoassay for the Melliamphetamino una interroyenids (THC), Opiates (OPI), Benzoylecgonine (COC), qualitative detection of Outmabilies (PCP) compounds and their metabolites Methamphetamine (m/mile (cut-off concentrations) of this test are as follows:
in human urine. The detection limits (cut-off concentrations) of this test are as follows: in numan unno: "The able, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Cannabinoids at 30 hgml, Oplates at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Alberts Sutz
Division Sign-Ot
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050594
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