(62 days)
No
The device description and performance studies indicate a simple lateral flow immunoassay that provides a visual qualitative result based on antigen-antibody binding, without any mention of computational analysis, algorithms, or learning processes.
No.
This device is a diagnostic tool used for the qualitative detection of amphetamine in urine and is not intended for treating or preventing disease.
Yes
This device is a rapid immunoassay designed for the qualitative detection of amphetamine in human urine, which serves as a diagnostic tool to identify the presence of the substance.
No
The device description clearly indicates it is a physical test strip and test device that utilizes immunochromatographic assays, which are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of amphetamine in human urine." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of amphetamine).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes "antigen-antibody immunochemistry" to detect a substance in a urine sample. This is a classic description of an in vitro diagnostic test.
- Sample Type: The test is performed on "human urine," which is a biological specimen.
- Purpose: The purpose is to detect the presence of amphetamine, which is a substance that can indicate drug use or exposure, providing diagnostic information.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of amphetamine in human urine at a cut-off concentration of 1,000 ng/mL. These tests are for professional and point of care use.
Product codes
DKZ
Device Description
The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of amphetamine, in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes a monoclonal antibody to selectively detect elevated levels of amphetamine in urine at a cut-off concentration of 1,000 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored line in the test line region. while a drug negative urine specimen will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region if the test has been 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 and point of care 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
Accuracy: A clinical evaluation was conducted using 300 specimens. Ten percent of these clinical specimens were enriched at +/- 25% levels of the cut-off concentration of 1,000 ng/mL. The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device were compared to the LifeSign Status DS AMP One-Step Amphetamine Test and Gas Chromatography/Mass Spectrometry (GC/MS).
Results for ACON AMP One Step Amphetamine Test Strip compared to LifeSign Status DS™ AMP One-Step Amphetamine Test:
Positive Agreement: 141 / 146 = 97%
Negative Agreement: 154 / 154 = 100%
Overall Agreement: 295 / 300 = 98%
Results for ACON AMP One Step Amphetamine Test Device compared to LifeSign Status DS™ AMP One-Step Amphetamine Test:
Positive Agreement: 140 / 146 = 96%
Negative Agreement: 154 / 154 = 100%
Overall Agreement: 294 / 300 = 98%
Results for ACON AMP One Step Amphetamine Test Strip compared to GC/MS:
Positive Agreement: 132 / 136 = 97% (93 - 99%)
Negative Agreement: 155 / 164 = 95% (90 - 93%)
Total Agreement: 287 / 300 = 96% (93 - 98%)
Results for ACON AMP One Step Amphetamine Test Device compared to GC/MS:
Positive Agreement: 131 / 136 = 96% (92 - 99%)
Negative Agreement: 155 / 164 = 95% (90 - 97%)
Total Agreement: 286 / 300 = 95% (92 - 97%)
Sensitivity: Tested amphetamine concentrations at 0, 500, 750, 1,000, 1,250, 1,500, and 2,000 ng/mL. Each concentration level was tested in 30 replicates for both devices. The data indicate 100% positive results at 125% and 150% above the cut-off concentration of 1,000 ng/mL, and 100% negative results at 50% below the cut-off concentration of 1,000 ng/mL.
Specificity: Specificity studies were conducted by individually spiking various amphetamine related compounds and metabolites into drug-free urine. Samples were diluted sequentially until the lowest concentration that yielded a positive result was identified. Examples given are D-Amphetamine (1,000 ng/mL, 100% cross reactivity), L-Amphetamine (50,000 ng/mL, 2% cross reactivity), D,L-Amphetamine (3,000 ng/mL, 33% cross reactivity), (+, -) - 3,4- Methylenedioxyamphetamine (MDA) (2,000 ng/mL, 50% cross reactivity), and Phentermine (3,000 ng/mL, 33% cross reactivity).
Interfering Substances: No interference was observed when testing negative or positive specimens containing listed substances at a final concentration of 100 ug/mL. Examples include 4-Acetamidophenol, Acetaphenetidine, Acetylsalicylic acid, Aminopyrine, Amitryptyline, Amobarbital, Caffeine, Cortisone, Creatinine, Dextromethorphan, Digoxin, Diphenhydramine, Ibuprofen, Morphine-3-B-D-Glucuronide, Phencyclidine, Prednisolone, Quinidine, Salicylic Acid, and Sulfamethazine.
Intra and inter-assay variability: Both the ACON Amphetamine Test Strip and Test Device demonstrated a high level of precision within run, between run and between days.
Key Metrics
Positive Agreement: 97% (Test Strip vs Predicate), 96% (Test Device vs Predicate)
Negative Agreement: 100% (Test Strip vs Predicate), 100% (Test Device vs Predicate)
Overall Agreement: 98% (Test Strip vs Predicate), 98% (Test Device vs Predicate)
Positive Agreement: 97% (93 - 99%) (Test Strip vs GC/MS), 96% (92 - 99%) (Test Device vs GC/MS)
Negative Agreement: 95% (90 - 93%) (Test Strip vs GC/MS), 95% (90 - 97%) (Test Device vs GC/MS)
Total Agreement: 96% (93 - 98%) (Test Strip vs GC/MS), 95% (92 - 97%) (Test Device vs GC/MS)
PPV (+): 94% (88 - 97%) (Test Strip vs GC/MS), 94% (88 - 97%) (Test Device vs GC/MS)
NPV (-): 97% (94 - 99%) (Test Strip vs GC/MS), 97% (93 - 99%) (Test Device vs GC/MS)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 3 1 2001
8. Summary of Safety and Effectiveness
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 KOI 1673
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121 Phone: 858-535-2030 Fax: 858-535-2035
Date:
May 16, 2001
Contact Person:
Edward Tung
Product Name:
ACON® AMP One Step Amphetamine Test Strip ACON® AMP One Step Amphetamine Test Device
Common Name:
Immunochromatographic test for the qualitative detection of amphetamine in urine specimens.
Device Classification:
The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are similar to other FDA-cleared devices for the qualitative detection of amphetamine in urine specimens. These tests are used to provide a preliminary analytical result. (21 CFR 862.3100). Amphetamine test systems have been classified as Class II devices, moderate complexity.
Classification Name:
Amphetamine test system
1
Intended Use:
The ACON® AMP One Step Amphetamine Test Strip and ACON® AMP One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of amphetamine in human urine at a cut-off concentration of 1,000 ng/mL
Description:
The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of amphetamine, in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes a monoclonal antibody to selectively detect elevated levels of amphetamine in urine at a cut-off concentration of 1,000 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored line in the test line region. while a drug negative urine specimen will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
Predicate Device:
LifeSign Status DS™ AMP One-Step Amphetamine Test
510(k) Number K945610
Distributor: LifeSign 71 Veronica Avenue Somerset, New Jersey 08873
Comparison to a Predicate Device:
A summary comparison of the features of the ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device and the LifeSign Status DS™ AMP One-Step Amphetamine Test is shown below.
- . Both tests are assays intended for the qualitative detection of amphetamine in urine samples.
- . Both tests are intended as a screening method that provides a preliminary analytical test result.
- . Both tests are immunochromatographic, lateral flow assays for rapid detection of amphetamine with a visual, qualitative end results.
- Both tests utilize the same basic immunoassay principles that rely on antigen / . antibody interactions to indicate a positive or negative result.
- . Both tests have a amphetamine cut-off concentration of 1,000 ng/mL.
2
Safety and Effectiveness Data:
Accuracy
Accuracy
A clinical evaluation was conducted using 300 specimens. Ten percent of these clinical A cinnear evaluation was condected 22% or -25% levels of the cut-off concentration of 1,000 specificas were enner at 12376 01 - 25,000 - 25,000 - 25,000 AMP AMP One ng mb methaniphonemanian Strip and the ACON® AMP One Step Amphetamine Test Device and the LifeSign Status DS AMP One-Step Amphetamine Test to the customary Gas and the Encelligh Status Do - Francery analysis technique. The data from this study yielded the following results:
ACON AMP One Step Amphetamine Test Strip compared to the LifeSign Status DS™ AMP One-Step Amphetamine Test:
Positive Agreement: 141 / 146 = 97% Negative Agreement: 154 / 154 = 100% 295 / 300 = 98% Overall Agreement:
ACON AMP One Step Amphetamine Test Device compared to the LifeSign Status DS AMP One-Step Amphetamine Test:
Positive Agreement: 140 / 146 = 96% Negative Agreement: 154 / 154 = 100% 294 / 300 = 98% Overall Agreement:
ACON AMP One Step Amphetamine Test Strip compared to GC/MS:
| Positive Agreement : 132 / 136 = 97% | (93 - 99%) * |
|---|---|
| Negative Agreement: 155 / 164 = 95% | (90 - 93%) * |
| Total Agreement: 287 / 300 = 96% | (93 - 98%) * |
| PPV (+): 132 / 141 = 94% | (88 - 97%) * |
| NPV (-): 155 / 159 = 97% | (94 - 99%) * |
ACON AMP One Step Amphetamine Test Device compared to GC/MS
| Positive Agreement:: | 131 / 136 = 96% | (92 - 99%) * |
|---|---|---|
| Negative Agreement: | 155 / 164 = 95% | (90 - 97%) * |
| Total Agreement: | 286 / 300 = 95% | (92 - 97%) * |
| PPV (+): | 131 / 140 = 94% | (88 - 97%) * |
| NPV (-): | 155 / 160 = 97% | (93 - 99%) * |
- Denotes 95% confidence intervals
3
Sensitivity
Sellshirty 500, 750, 1,000, 1,250, 1,500 and 2,000 ng/mL. Each concentration level was tested in 500, 750, 1,000, 1,200, 1,200, 1,200, AMP One Step Amphetamine 2001 ropheater of and One Step Amphetamine Test Device. The data indicate 100% aller 1001 - 1172 One and 50% below the cut-off concentration of 1,000 ng/mL.
| Amphetamine | Visual Result | |||
|---|---|---|---|---|
| Concentration (ng/mL) | % Cut-off | n | Negative | Positive |
| Negative urine | 0 | 30 | 30 | 0 |
| 500 ng/mL | 50% | 30 | 30 | 0 |
| 750 ng/mL | 75% | 30 | 22 | 8 |
| 1,000 ng/mL | Cut-off | 30 | 12 | 18 |
| 1,250 ng/mL | 125% | 30 | 2 | 28 |
| 1,500 ng/mL | 150% | 30 | 0 | 30 |
| 2,000 ng/mL | 200% | 30 | 0 | 30 |
Analytical sensitivity of the ACON Amphetamine Test Strip
Analytical sensitivity of the ACON Amphetamine Test Device
| Amphetamine
| Concentration (ng/mL) | % Cut-off | n | Visual Result | |
|---|---|---|---|---|
| Negative urine | 0 | 30 | 30 | 0 |
| 500 ng/mL | 50% | 30 | 30 | 0 |
| 750 ng/mL | 75% | 30 | 23 | 7 |
| 1,000 ng/mL | Cut-off | 30 | 9 | 21 |
| 1,250 ng/mL | 125% | 30 | 1 | 29 |
| 1,500 ng/mL | 150% | 30 | 0 | 30 |
| 2,000 ng/mL | 200% | 30 | 0 | 30 |
Specificity
Specificity studies were conducted by individually spiking various amphetamine related compounds and metabolites into drug-free urine. These samples were further diluted sequentially to different concentrations until the lowest concentration that yielded a positive result was identified. The following compounds gave positive results at the respective concentrations. The % Cross Reactivity was determined from these concentrations.
| Compounds | Concentration (ng/mL) | % Cross Reactivity |
|---|---|---|
| D-Amphetamine | 1,000 | 100 |
| L-Amphetamine | 50,000 | 2 |
| D,L-Amphetamine | 3,000 | 33 |
| (+, -) - 3,4- Methylenedioxyamphetamine (MDA) | 2,000 | 50 |
| Phentermine | 3,000 | 33 |
4
Interfering Substances
Interference was observed in our studies when using negative or positive specimens No interence was observed in our in out ining the following substances at a final concentration of 100 ug/mL:
| 4-Acetamidophenol | Estrone 3 Sulfate | Oxazepam | Trimipramine |
|---|---|---|---|
| Acetaphenetidine | Ethyl -p- aminobenzoate | Oxolinic Acid | Tryptamine |
| N-Acetylprocainamide | Fenoprofen | Oxycodone | D,L - Tryptophan |
| Acetylsalicylic acid | Furosemide | Oxymetazoline | Tyramine |
| Aminopyrine | Gentisic Acid | Promazine | Uric Acid |
| Amitryptyline | Hydralazine | Promethazine | Verapamil |
| Amobarbital | Hydrochlorothiazide | D -L - Propanolol | Zomepirac |
| L-Ascorbic acid | Hydrocodone | D - Propoxyphene | Ampicillin |
| Amoxicillin | Hydrocortisone | D- Pseudoephedrine | Caffeine |
| Apomorphine | O-Hydroxyhippuric Acid | Papaverine | (±)Chlorpheniramine |
| Aspartame | P-Hydroxymethamphetamine | Pennicillin - G | Brompheniramine |
| Atropine | 3-Hydroxytyramine | Pentobarbital | Ranitidine |
| Benzilic Acid | Ibuprofen | Perphenazine | Cannabinol |
| Benzoic Acid | Imipramine | Phencyclidine | P-Hydroxyamphetamine |
| Benzoylecgonine | Iproniazide | Phenelzine | (1R), (2S)- (-)- Ephedrine |
| Benzphetamine | (-)Isoproternol | Phenolbarbital | (L)- Ephedrine |
| Bilirubin | Isoxsuprine | L - Phenylephrine | Fenfluramine |
| Canabidiol | Ketamine | B - Phenylethlamine | 3,4-Methylenedioxyethy- |
| amphetamine (MDE) | |||
| Chloralhydrate | Ketoprofen | Phenylpropanolamine | (L)- MAMP |
| Chloramphenicol | Labetanol | Prednisolone | (D)- MAMP |
| Chlordiazepoxide | Levophenol | Procaine | |
| Chlorothiazide | Loperamide | Prednisone | |
| Chlopromazine | Hemoglobin | Quinidine | |
| Chloroquine | Maprotiline | Quinine | |
| Cholesterol | Meprobamate | Salicylic Acid | |
| Clomipramine | Methadone | Secobarbital | |
| Clonidine | Meperidine | Serotonin | |
| Codeine | Methoxyphenamine | Sulfamethazine | |
| Cortisone | (+)3,4Methylenedioxy | Sulindac | |
| Methamphetamine | |||
| (-) Cotinine | Methylphenidate | Temazepam | |
| Creatinine | Morphine-3-B-D-Glucuronide | Tetracyline | |
| Deoxycorticosterone | Nalidixic Acid | Tetrahydrocortison3 Acetate | |
| Dextromethorphan | Naloxone | Tetrahydrocortisone-3B-D | |
| Glucuronide | |||
| Diazepam | Naltrexone | Tetrahydrozoline | |
| Diclofenac | Naproxene | Thiamine | |
| Diflunisal | Niaciamide | Thebaine | |
| Digoxin | Nifedipine | Thioridazine | |
| Diphenhydramine | Norcodeine | D,L - Tyrosine | |
| Doxylamine | Norothindrone | Tolbutamine | |
| Ecgonine methylester | D-Norpropoxyphene | Trans-2- | |
| phenylcyclopropglamine | |||
| (-)Y-Ephedrine | Noscapine | Triamterene | |
| Erythromycine | D,L Octopamine | Trifluoperazine | |
| B-Estadiol | Oxalic Acid | Trimethoprime |
5
Intra and inter-assay variability
Intra and inter-assay variability
Both the ACON® Amphetamine Test Strip and Test Device demonstrated a high level of precision within run, between run and between days.
Conclusion
Conclusion
These studies demonstrate the substantial equivalency of the ACON® AMP One Step These studies domonstant and Parting AMP One Step Amphetamine Test Device to the Alliphelanine Test Strip and NOOT Amphetamine Test, which is already marketed. They Lifesign Status DS - ANIL One Stop Fridant for professional and point-of-care use, in addition to demonstrating their safety and effectiveness.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 3 1 2001
Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego. CA 92121
510(k) Number: K011673 Re: JTV(K) Nambor. Trol 1070.
Trade/Device Name: ACON® AMP One Step Amphetamine Test Strip and ACON® AMP One Step Amphetamine Test Device Regulation Number: 862.3100 Regulatory Class: II Product Code: DKZ Dated: May 16, 2001 Received: May 30, 2001
Dear Dr. Tung:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your books be device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersule commerce prior of they been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I coderal Food, Drag, and Cochine Sec. The general controls provisions of the Act include the goneral controls provegistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer rippto rate) of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing i A substantially of arraneral (GMP) regulation (21 CFR Part 820) and that, through I ractive for Moulear Dons, the Food and Drug Administration (FDA) will verify such periodic Offir mspoculonsymbility with the GMP regulation may result in regulatory action. In assumptions: Thanks to ventify her announcements concerning your device in the Federal addition, I Dri may packet to your premarket notification submission submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the ally oongation you mig-ation Control provisions, or other Federal laws or regulations.
7
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) prematked This letter will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivaled or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitto diagnostic devices), please contact the Office of additionally 809.10 for in vitto dagnostic and the promotion and advertising of your device,
(301) 594-4588. Additionally, for questions on the promotion and advertising of (301) 594-4588. Additionally, for questions on and pressence the regulation
please contact the Office of Compliance at (311) 594-4639. Also, please note the regulation please contact the Office of Compliance at (30) - 10.07 - 1.03) CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Ot entitled, "Misbranding by reference oplemants. Invanced from the Division of Small
information on your responsibilities under the Act may be obtained from the 1000 mg its information on your responsibilities under (800) 638-2041 or (301) 443-6597 or at its
Manufacturers Assistance at its toll-free humber (800) 638-2041 or (301) 443-6597 or at Manufacturers Assistance at tts ton 1100 andsmamain.html".
internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATIONS FOR USE 10.
510(k) Number:
KOII673
Device Name:
Indications for Use:
ACON® AMP One Step Amphetamine Test Strip ACON® AMP One Step Amphetamine Test Device
The ACON AMP One Step Amphetamine Test Strip and ACON AMP One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of amphetamine in human urine at a cut-off concentration of 1,000 anphetalling these tests are for professional and point of care use.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K011673
(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺮ
Or Over-The-Counter Use
(Per 21 CFR 801.109)