(36 days)
Not Found
Not Found
No
The 510(k) summary describes a qualitative in vitro diagnostic test using test strips and does not mention any computational analysis, image processing, or AI/ML terms.
No.
Explanation: The device is an in vitro screen test for qualitative detection of multi-drugs in human urine, used for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is an in vitro screen test for the qualitative detection of multi-drugs in human urine, providing a preliminary result that guides clinical consideration. This function of identifying specific substances in a biological sample to inform further medical evaluation or treatment aligns with the definition of a diagnostic device, even though it provides only a preliminary result that needs confirmation.
No
The device description explicitly states it is an "In Vitro screen test device" that uses "multiple test strips in card format, cassette format, and cup format," indicating it is a physical device with hardware components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "In Vitro screen test device for the qualitative detection of multi-drugs in human urine." The term "In Vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The "Device Description" also reiterates that it is an "In Vitro screen test device."
- Sample Type: The device analyzes "human urine," which is a biological sample taken from the body, another common feature of IVDs.
- Purpose: The purpose is to detect substances (multi-drugs) within this biological sample to provide information about a person's health or condition.
Therefore, based on the provided information, the Ameditech ImmuTest Multi-Drug Screen Panel III clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
| Test | Calibrator | · Cutoff(ng/ml) |
|---|---|---|
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET1000) | Methamphetamine | 1000 |
| Opiates (OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Methadone (MTD) | Methadone | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| 3,4methylenedioxymethamphetamine(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
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 Spectroscopy (GC/MS) is the preferred confirmation method.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM
Device Description
The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result.
Mentions image processing
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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
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)
Not Found
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.
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, which is a stylized representation of the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 4 - 2005
John Wu, Ph.D. Director of Quality Assurance Ameditech, Inc. 10340 Camino Santa Fe Suite F San Diego, CA 92121
Re: K050186
Trade/Device Name: Ameditech ImmuTest Multi-Drug Screen Panel III Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM Dated: January 21, 2005 Reccived: January 28, 2005
Dear Dr. Wu:
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) This letter will anow you to oogin maneting of substantial equivalence of your device to a legally premarket notification: "The PDs 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 or quottons on the promie Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I bu may oount oner getierers, 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,
Jean M. Cooper, MS, DVM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Ameditech ImmuTest Multi-Drug Screen Panel III
Indications For Use:
The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
| Test | Calibrator | · Cutoff
(ng/ml) |
|--------------------------------------------|----------------------------------|---------------------|
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET1000) | Methamphetamine | 1000 |
| Opiates (OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Methadone (MTD) | Methadone | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| 3,4methylenedioxymethamphetamine
(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
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 Spectroscopy (GC/MS) is the preferred confirmation method.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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