ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE

K033299 · ACON Laboratories, Inc. · LAF · Dec 12, 2003 · Clinical Toxicology

Device Facts

• Record ID: K033299
• Device Name: ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Indications for Use

The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine, a central nervous stimulating drug, in urine. Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose. This assay provides only a preliminary result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.

Device Story

Rapid immunochromatographic assay; detects methamphetamine in human urine. Principle: competitive binding; drug in urine competes with drug conjugate for antibody binding sites. Input: urine specimen applied via dipping (strip) or dropper (device). Output: visual colored lines in control and test regions. Negative result: colored line in test region; positive result: no line in test region. Used in physician offices/clinical settings; operated by healthcare personnel. Provides preliminary analytical result; requires confirmation via GC/MS or alternative chemical method. Assists clinicians in diagnosing/treating methamphetamine use or overdose.

Clinical Evidence

Clinical evaluation of 300 urine specimens compared subject devices against a predicate device and GC/MS. Total agreement with GC/MS was 98% for both the test strip and test device. Positive agreement with GC/MS was 100% (strip) and 99% (device); negative agreement was 97% (strip) and 98% (device).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format. Utilizes mouse monoclonal antibodies. Qualitative visual readout. No instrumentation required. Cutoff concentration 500 ng/mL.

Indications for Use

Indicated for qualitative detection of methamphetamine in urine for diagnosis and treatment of methamphetamine use or overdose in patients. Intended for use by healthcare professionals, including at point-of-care sites.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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).

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number: K033299
B. Analyte: methamphetamine
C. Type of Test: lateral flow immunochromatographic
D. Applicant: ACON Laboratories, Inc.
E. Proprietary and Established Names: ACON® mAMP 500 One Step Methamphetamine Test Strip and ACON® mAMP 500 One Step Methamphetamine Test Device

F. Regulatory Information:
1. Regulation section: 21 CFR § 862.3610
2. Classification: Class II
3. Product Code: LAF
4. Panel: Clinical Toxicology

G. Intended Use:
1. Indication(s) for use:
The ACON® mAMP 500 One Step Methamphetamine Test Strip and ACON® mAMP 500 One Step Methamphetamine Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine in human urine at a cutoff concentration of 500 ng/mL. Measurements obtained by the strip and device are used in the diagnosis and treatment of methamphetamine use or overdose.
2. Special condition for use statement(s):
The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device provide only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/Mass spectrometry is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used. For prescription use only.

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3. Special instrument Requirements: N/A

H. Device Description: The test strip is held at one end while the other end (indicated by a line) is dipped in the urine specimen. The control (C) and test (T) areas are in the middle of the strip and are used to read the test result. The test device uses a strip enclosed in a plastic cassette. The urine is applied to a sample well (S) by means of a dropper. Control and test regions in the middle are similar to the strip.

I. Substantial Equivalence Information:

1. Predicate device name(s): Instant-View Methamphetamine (500) Urine Test
2. Predicate K number(s): K994406
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indications for Use | Same | Qualitative detection of methamphetamine in urine |
| Methodology | Same | Lateral flow immunoassay |
| Endpoint | Same | Visible Lines |
| Cutoff | Same | 500 ng/mL |
| Antibodies | Same | Goat, Mouse |
| Differences | | |
| Item | Device | Predicate |
| Read Time | 5 minutes to 4 hours | 4 to 7 minutes |

J. Standard/Guidance Document Referenced (if applicable):

None referenced

K. Test Principle:

The mAMP 500 One Step Methamphetamine Test Strip and Test Device are immunoassays based on the principle of competitive binding. Methamphetamine which may be present in the urine specimen competes with the drug conjugate for binding sites on the antibody.

During testing with the strip or device, a urine specimen is applied by dipping or using a dropper and migrates by capillary action. Methamphetamine, if present in the urine specimen below 500 ng/mL, will not saturate the binding sites of antibody-coated particles in the strip or device. The antibody-coated particles will then be captured by immobilized Methamphetamine conjugate and a visible colored line will appear in the test line region. The colored line will not form in the test line region if the Methamphetamine level exceeds 500 ng/mL because the methamphetamine present will saturate all the binding sites of anti-Methamphetamine antibodies.

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A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off 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, indicating that proper volume of specimen has been added and membrane wicking has occurred.

## L. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

**For the test strip:**

A study was conducted at 3 physician’s offices by untrained operators using 3 different lots of product. An identical panel of coded specimens containing no Methamphetamine, 25% Methamphetamine above and below the cut-off and 50% Methamphetamine above and below the 500 ng/mL cut-off was provided to each site. Results were as follows:

| Methamphetamine concentration (ng/mL) | n | Site A | | Site B | | Site C | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | - | + | - | + | - | + |
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 250 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 375 | 15 | 15 | 0 | 10 | 5 | 15 | 0 |
| 625 | 15 | 1 | 14 | 0 | 15 | 2 | 13 |
| 750 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |

**For the test device:**

A study was conducted at 3 physician’s offices by untrained operators using 3 different lots of product. An identical panel of coded specimens containing no Methamphetamine, 25% Methamphetamine above and below the cut-off and 50% Methamphetamine above and below the 500 ng/mL cut-off was provided to each site. Results were as follows:

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| Methamphetamine concentration (ng/mL) | n | Site A | | Site B | | Site C | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | - | + | - | + | - | + |
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 250 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 375 | 15 | 15 | 0 | 10 | 5 | 15 | 0 |
| 625 | 15 | 1 | 14 | 1 | 14 | 2 | 13 |
| 750 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |

b. Linearity/assay reportable range:
N/A

c. Traceability (controls, calibrators, or method):

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

The manufacturer does not supply control materials with these devices, but recommends that a positive and negative control be tested to confirm the test procedure and to verify proper test performance.

d. Detection limit:
These assays are designed to produce a positive result for methamphetamine at a concentration of 500 ng/mL or greater.

e. Analytical specificity:
The specificity of these assays was evaluated using several methamphetamine-related compounds. Results were as follows:

| Compound | Concentration (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| D-Methamphetamine | 500 | 100% |
| D-Amphetamine | 50,000 | 1% |
| D/L-Amphetamine | 75,000 | <1% |
| Chloroquine | 12,500 | 4% |
| (±)-3,4-Methylenedioxymethamphetamine | 1,000 | 50% |
| P-Hydroxymethamphetamine | 15,000 | <1% |
| Mephentermine | 25,000 | 2% |
| (1R,2S)-(-)-Ephedrine | 50,000 | 1% |
| L-Phenylephrine | 100,000 | <1% |
| β-Phenylethylamine | 75,000 | <1% |

In addition, approximately 150 common drugs and endogenous substances were tested for possible cross-reactivity at 100 µg/mL. None

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of the substances tested caused a positive result with the methamphetamine strip or device.

f. Assay cut-off:
See detection limit above.

2. Comparison studies:

a. Method comparison with predicate device:
Performance was compared with the predicate device with the following results:

For the test strip:
| Method | | Other mAMP Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| mAMP 500 One Step Test Strip | Results | Positive | Negative | |
| | Positive | 108 | 39* | 147 |
| | Negative | 0 | 153 | 153 |
| Total Results | | 108 | 192 | 300 |
| % Agreement with this commercial kit | | >99% | 80% | 87% |

*32 specimens were shown by GC/MS to be greater than 500 ng/mL in concentration.

For the test device:
| Method | | Other mAMP Rapid Test | | Total Results |
| --- | --- | --- | --- | --- |
| mAMP 500 One Step Test Device | Results | Positive | Negative | |
| | Positive | 108 | 34* | 142 |
| | Negative | 0 | 158 | 158 |
| Total Results | | 108 | 158 | 300 |
| % Agreement with this commercial kit | | >99% | 82% | 89% |

*32 specimens were shown by GC/MS to be greater than 500 ng/mL in concentration.

Performance was also compared with the reference method GC/MS, with the following results:

For the test strip:
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| mAMP 500 One Step Test Strip | Results | Positive | Negative | |
| | Positive | 140 | 7 | 147 |
| | Negative | 0 | 153 | 153 |
| Total Results | | 140 | 160 | 300 |
| % Agreement with GC/MS Analysis | | >99% | 96% | 98% |

For the test device:
| Method | | GC/MS | | Total Results |
| --- | --- | --- | --- | --- |
| mAMP 500 One Step Test Device | Results | Positive | Negative | |
| | Positive | 139 | 7 | 146 |
| | Negative | 1 | 153 | 154 |
| Total Results | | 140 | 160 | 300 |
| % Agreement with GC/MS Analysis | | >99% | 97% | 98% |

b. Matrix comparison:
N/A

3. Clinical studies:

a. Clinical sensitivity:
N/A

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b. Clinical specificity:
N/A

c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
Methamphetamine is not found in the urine of individuals who have not ingested methamphetamine or a related substance.

M. Conclusion:
Based upon the information provided for the file, I recommend that the ACON® mAMP 500 One Step Methamphetamine Test Strip and ACON® mAMP 500 One Step Methamphetamine Test Device be found substantially equivalent to the predicate device.