← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K040133

# URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE (K040133)

_Dade Behring, Inc. · DKZ · Apr 8, 2004 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K040133

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** Apr 8, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The AMPH Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.

## Device Story

The Dimension® AMPH method is an in vitro diagnostic reagent cartridge for use on Dade Behring Dimension® clinical chemistry systems. It utilizes a homogeneous enzyme immunoassay (Emit® technology) to detect amphetamines and methamphetamine in human urine. The assay relies on competition between the drug in the urine specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity is inhibited upon binding to the antibody; active enzyme converts NAD to NADH, producing an absorbance change measured spectrophotometrically at 340nm. The device is used in clinical laboratory settings by trained personnel. Results are used by clinicians to aid in the diagnosis and treatment of drug use or overdose. Because the assay provides only preliminary results, positive findings require confirmation via a more specific method like GC/MS. The system provides qualitative or semi-quantitative results based on user-selected cutoffs (300, 500, or 1000 ng/mL).

## Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per NCCLS EP5-A (20 days, duplicate analysis). Analytical performance characterized via linearity, sensitivity (125 ng/mL at 1000 ng/mL cutoff; 95 ng/mL at 300/500 ng/mL cutoffs), and specificity (cross-reactivity profiles for various compounds). Method comparison studies performed against the predicate device and GC/MS confirmation on 129-169 urine specimens per cutoff level, demonstrating concordance.

## Technological Characteristics

Homogeneous enzyme immunoassay; prepackaged plastic reagent cartridge (Flex®). Designed for use on Dimension® clinical chemistry system. Analyte: Amphetamines/Methamphetamine. Cutoffs: 300, 500, 1000 ng/mL.

## Regulatory 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.

## Special Controls

*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).

## Predicate Devices

- Syva® Emit® II Plus Amphetamine Assay ([K031004](/device/K031004.md))

## Submission Summary (Full Text)

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

A. 510(k) Number: K040133

B. Purpose for Submission:
Premarket Notification 510(k) of intention to manufacture and market a new device, Dimension® Urine Amphetamine/Methamphetamine Screen Flex® reagent cartridge (DF91B)

C. Analyte: Amphetamine

D. Type of Test:
Qualitative or Semi-Quantitative homogeneous enzyme immunoassay

E. Applicant: Dade Behring Inc.

F. Proprietary and Established Names:
Dimension® Urine Amphetamine/Methamphetamine Screen Flex® reagent cartridge

G. Regulatory Information:
1. Regulation section: 21CFR §862.3100 Amphetamine test system
2. Classification: Class II
3. Product Code: DKZ
4. Panel: Toxicology (91)

H. Intended Use:
1. Intended use(s):
The AMPH Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.

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2. **Indication(s) for use:**

Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.

3. **Special condition for use statement(s):**

The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) 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.

4. **Special instrument Requirements:**

To be used on Dade Behring Dimension® clinical chemistry systems for the qualitative and semi-quantitative determination of amphetamines in human urine.

I. **Device Description:**

The Dade Behring Dimension® AMPH method is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.

|  Wells^{a} | Form | Ingredient | Concentration | Source  |
| --- | --- | --- | --- | --- |
|  1 | Empty |  |  |   |
|  2,3 | Liquid | d-amphetamine and d-methamphetamine enzyme conjugates^{b}, bovine serum albumin | B |   |
|  4 | Empty |  |  |   |
|  5,6 | Liquid | Monoclonal antibodies^{b} reactive to d-amphetamine and d-methamphetamine, bovine serum albumin, NAD+, G6P | B | mouse  |
|  7 | Empty |  |  |   |
|  8 | Liquid | Monoclonal antibodies^{b} reactive to d-amphetamine and d-methamphetamine, bovine serum albumin, NAD+, G6P | B | mouse  |

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# J. Substantial Equivalence Information:

1. Predicate device name(s): Syva® Emit II Plus Amphetamine Assay
2. Predicate K number(s): k031004
3. Comparison with predicate:

This product is substantially equivalent to other enzyme Immunoassay Amphetamine assays, such as the Syva® Emit II Plus Amphetamine Assay (k031004) for the 30-R Biochemical System

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | Dade Behring Inc.
Amphetamine/Methamphetamine Assay (K040133) | Syva® Emit II Plus
Amphetamine Assay for the 30-R Biochemical System (K031004)  |
|  Intended Use | in-vitro use, qualitative and semi-quantitative analysis of amphetamines | in-vitro use, qualitative and semi-quantitative analysis of amphetamines  |
|  Sample Type | Human Urine | Human Urine  |
|  Cutoffs | 300, 500, or 1000 ng/mL | 300, 500, or 1000 ng/mL  |
|  Technology | Homogeneous Enzyme Immunoassay Emit® Technology | Homogeneous Enzyme Immunoassay Emit® Technology  |
|  Main Ingredients | Monoclonal antibodies reactive to d-amphetamine and d-methamphetamine NAD+, G6P | Monoclonal antibodies reactive to d-amphetamine and d-methamphetamine NAD+, G6P  |

# K. Standard/Guidance Document Referenced (if applicable):

Reproducibility testing was done in accordance with the NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A, 1999.

# L. Test Principle:

The Dade Behring Dimension® clinical chemistry system Flex® Reagent Cartridge Urine/Amphetamine/Methamphetamine Screen Flex® reagent cartridge assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in human urine. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the

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antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay. The reaction sequence is shown below:

$$
\begin{array}{c c c c c} \mathrm {A b + A M P H} & + & \mathrm {A M P H -} & \rightarrow & \mathrm {A b - A M P H + A b - A M P H - G 6 P D H} & + \mathrm {A M P H -} \\ & & \mathrm {G 6 P D H} & & (\text {inhibited}) & \mathrm {G 6 P D H} \\ & & & & (\text {active}) \end{array}
$$

$$
\begin{array}{c c c c c} \text {Glucose-6-} & + & \mathrm {N A D +} & \mathrm {A M P H - G 6 P D H} & \rightarrow & 6 - \text {phosphogluconolactone} + \mathrm {N A D H} + \mathrm {H} \\ \text {Phosphate} & & & (\text {active}) & & (\text {absorbs at 340nm}) \end{array}
$$

Where:

Ab= antibody reactive to d-amphetamine and d-methamphetamine

AMPH = amphetamines and methamphetamine

AMPH-G6PDH = d-amphetamine and d-methamphetamine glucose-6-

dehydrogenase conjugates.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Syva Emit® Cutoff Calibrators (levels 300, 500, and 1000 ng/mL) and in-house controls (levels 225, 375, 625, 750 and 1250 ng/mL) prepared at Date Behring were analyzed in duplicate for 20 days. The within-run and total coefficients of variation (%CV) were calculated by the analysis of variance method according to the National Committee of Clinical Laboratory Standards (NCCLS) Guideline EP5-A (February 1999).

|  Calibrator/Control^{d} | Reproducibility at 300 and 500 ng/mL cutoffs  |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |  | Within |   | Total  |   |
|   | Mean | SD | CV | SD | CV  |
|  ng/mL | ng/mL | ng/mL | % | ng/mL | %  |
|  225 | 228 | 11.2 | 4.9 | 23.3 | 10.2  |
|  300 | 290 | 11.2 | 3.9 | 23.2 | 8.0  |
|  375 | 375 | 9.6 | 2.6 | 26.8 | 7.1  |
|  500 | 499 | 35.4 | 7.1 | 38.7 | 7.9  |
|  625 | 661 | 38.4 | 5.8 | 55.3 | 8.4  |
|  Calibrator/Control^{d} | Reproducibility at 1000 ng/mL cutoffs  |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |  | Within |   | Total  |   |
|   | Mean | SD | CV | SD | CV  |
|  ng/mL | ng/mL | ng/mL | % | ng/mL | %  |
|  750 | 766 | 24.1 | 3.1 | 36.2 | 4.7  |
|  1000 | 1006 | 20.0 | 2.0 | 28.5 | 2.8  |
|  1250 | 1285 | 44.3 | 3.4 | 60.0 | 4.7  |

d = Syva® Emit® calibrators and in house controls

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# b. Linearity/assay reportable range:

Samples were prepared by spiking known amounts of methamphetamine and amphetamine into a negative urine pool. Mean results in the qualitative and semi-quantitative modes were calculated from 5 replicates of each spikes level.

Mean results of methamphetamine and amphetamine spikes, were correctly qualified as negative or positive relative to each of the three cutoffs in the semi-quantitative mode.

Qualitative Recovery

|  SampleVolume: | 3μL | 6 μL  |   |
| --- | --- | --- | --- |
|   | Qualitative Result Relative to 1000 cutoff (+/-) | Qualitative Result Relative to 300 cutoff (+/-) | Qualitative Result Relative to 500 cutoff (+/-)  |
|  Cutoff Rate (mau/min) | 216.0 | 183.3 | 210.8  |
|  Meth (ng/mL) |  |  |   |
|  150 |  | - | -  |
|  200 | - | - | -  |
|  350 | - | + | -  |
|  450 | - | + | -  |
|  600 | - | + | +  |
|  750 | - | + | +  |
|  900 | - | + | +  |
|  1300 | + | + | +  |
|  1500 | + | + | +  |
|  1800 | + | + | +  |
|  Amph (ng/mL) |  |  |   |
|  150 |  | - | -  |
|  200 | - | - | -  |
|  350 | - | + | -  |
|  450 | - | + | -  |
|  600 | - | + | +  |
|  750 | - | + | +  |
|  900 | - | + | +  |
|  1300 | + | + | +  |
|  1500 | + | + | +  |
|  1800 | + | + | +  |

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# Semiquantitative Recovery

|  Nominal | 3 μL/ 1000 ng/mL Meth
Mean Conc. Of Spiked Sample |   | 6 μL/ 1000 ng/mL Meth
Mean Conc. Of Spiked Sample  |   |
| --- | --- | --- | --- | --- |
|  (ng/mL) | ng/mL | % | ng/mL | %  |
|  Meth |  |  |  |   |
|  150 |  |  | 135 | 90%  |
|  200 | 238 | 119% | 201 | 100%  |
|  350 | 393 | 112% | 354 | 101%  |
|  450 | 490 | 109% | 478 | 106%  |
|  600 | 629 | 105% | 591 | 98%  |
|  750 | 777 | 104% | 812 | 108%  |
|  900 | 901 | 100% | 902 | 100%  |
|  1300 | 1384 | 106% |  |   |
|  1500 | 1510 | 101% |  |   |
|  1800 | 1958 | 109% |  |   |
|  Amph |  |  |  |   |
|  150 |  |  | 202 | 135%  |
|  200 | 173 | 86% | 217 | 108%  |
|  350 | 406 | 116% | 319 | 91%  |
|  450 | 457 | 102% | 467 | 104%  |
|  600 | 591 | 98% | 643 | 107%  |
|  750 | 635 | 85% | 698 | 93%  |
|  900 | 989 | 110% | 736 | 82%  |
|  1300 | 1235 | 95% |  |   |
|  1500 | 1329 | 89% |  |   |
|  1800 | 1542 | 86% |  |   |

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

The calibrators referenced in the package insert are sold separately and are in commercial distribution in the USA. They are distributed as Syva® Emit® Calibrator, levels 0-5. These calibrators were cleared by the FDA under Document Control No. k993755 on December 21, 1999.

## d. Detection limit:

The sensitivity of the AMPH method is 125 ng/mL for the 1000 ng/mL cutoff (3μL sample size) and it represents the lowest concentration of AMPH that can be distinguished from zero. The sensitivity of the AMPH method is 95 ng/mL for the 300 and 500 ng/mL cutoffs (6 μL sample size). Sensitivity is defined as the concentration at two standard deviations above 0 ng/mL using Emit® Calibrator level 0 calibrator (n = 20).

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# e. Analytical specificity:

The tables below give the compounds this assay is designed to detect and the level at which the compounds have been found to give a response approximately equivalent to that of the selected cutoff (300, 500, or  $1000\mathrm{ng / mL}$  d-methamphetamine).

Each concentration represents the reactivity level for the stated compound when it is added to a negative urine specimen. If a sample contains more than one compound detected by the assay, lower concentrations than those listed below may combine to produce a rate approximately equivalent to or greater than that of the cutoff calibrator.

Concentration of amphetamines producing a result approximately equivalent to the selected cutoff (300, 500, or  $1000\mathrm{ng / mL}$ ) d-methamphetamine cutoffs:

|   | Concentration (ng/mL) Giving a Response Approximately Equivalent to the Cutoff  |   |   |
| --- | --- | --- | --- |
|  Compound | 300 ng/mL cutoff | 500 ng/mL cutoff | 1000 ng/mL cutoff  |
|  d-Amphetamine * | 329 | 529 | 1286  |
|  d, l-Amphetamine | 528 | 1058 | 2139  |
|  d, l-Methamphetamine | 491 | 818 | 1564  |
|  l-Amphetamine | 2509 | 4996 | 10407  |
|  l-Methamphetamine | 526 | 1049 | 2273  |
|  Methylenedioxyamphetamine (MDA) | 1515 | 2410 | 3537  |
|  Methylenedioxymethamphetamine (MDMA) | 3729 | 9594 | 20538  |
|  Methylenedioxyethamphetamine (MDEA) | 3286 | 8359 | 18230  |

Concentration of amphetamines producing a result approximately equivalent to the selected cutoff (300, 500, or  $1000\mathrm{ng / mL}$ ) d-methamphetamine cutoffs:

|   | Concentration (ng/mL) Giving a Response Approximately Equivalent to the Cutoff  |   |   |
| --- | --- | --- | --- |
|  Compound | 300 ng/mL cutoff | 500 ng/mL cutoff | 1000 ng/mL cutoff  |
|  4-Chloramphetamine | 2 | 5 | 10  |
|  Benzphetamine * | 1 | 1 | 1  |
|  Bupropion | 175 | 510 | 1038  |
|  Chloroquine | 608 | 1687 | 3741  |
|  l-Ephedrine | 355 | 1109 | 2242  |
|  Fenfluramine | 17 | 45 | 105  |
|  Mephentermine | 6 | 15 | 30  |
|  Methoxyphenamine | 61 | 153 | 331  |
|  Nor-pseudoephedrine | 40 | 93 | 188  |

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|  Phenmetrazine | 2 | 4 | 9  |
| --- | --- | --- | --- |
|  Phentermine | 4 | 10 | 21  |
|  Phenylpropanolamine (PPA) | 26 | 61 | 133  |
|  Propanolol | 64 | 175 | 386  |
|  Pseudoephedrine | 987 | 2834 | 5889  |
|  Quinacrine | 1303 | 3776 | 8293  |
|  Tranylcypromine | 28 | 59 | 126  |
|  Tyramine | 98 | 232 | 503  |

*Benzphetamine metabolizes to amphetamine and methamphetamine.

Note: Selegiline, a prescription medication used in the treatment of Parkinson's disease, metabolizes to l-amphetamine and l-methamphetamine. Therefore, patients taking Selegiline may test positive by amphetamine assays.

Note: Specimens from patients taking chlorpromazine (Thorazine®) may produce positive results with this assay.

# f. Assay cut-off:

Assay cutoffs are 300, 500 or  $1000\mathrm{ng / Ml}$ . (See precision/ reproducibility studies above).

# 2. Comparison studies:

# a. Method comparison with predicate device:

Method comparison (cutoff = 300 ng/mL)

129 urine specimens were tested with the AMPH Flex® cartridge on the Dimension® system (cutoff = 300 ng/mL) and with the Syva® Emit® LL Plus Amphetamine Assay (9C309UL) on the Syva 30R® Biochemical System (cutoff = 300 ng/mL). All 129 specimens were also analyzed by GC/MS. Positives by GC/MS were determined by using criteria of amphetamine plus methamphetamine ≥300 ng/mL since there are no SAMSHA confirmation guidelines for the 300 cutoff. 24 of these specimens had total amphetamines by GC/MS within 25% of the 300 ng/mL cutoff. Results are summarized in the tables below:

|  AMPH Flex® Reagent Cartridge on the Dimension® clinical chemistry system (cutoff 300 ng/mL) |  | Syva 30R® Biochemical System (cutoff 300 ng/mL)  |   |
| --- | --- | --- | --- |
|   |   | Positive | Negative  |
|   |  Positive | 70 | 2  |
|   |  Negative | 2 | 55  |

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Discrepant s (ng/mL):

|  GC/MS | GC/MS | GC/MS | Dimension | Syva  |
| --- | --- | --- | --- | --- |
|  Meth | Amph | Total | AMPH | 30R  |
|  242 | 61.1 | 303 | 315 | 273  |
|  433 | < lod | 433 | 325 | 298  |
|  275 | 70.2 | 345 | 278 | 300  |
|  363 | < lod | 363 | 204 | 301  |

&lt; lod: less than the limit of detection, &lt; 25 ng/mL

|  AMPH Flex®
Reagent Cartridge
on the Dimension®
clinical chemistry
system (cutoff 300
ng/mL) |  | GC/MS (cutoff 300 ng/mL
methamphetamine and amphetamine)  |   |
| --- | --- | --- | --- |
|   |   | Positive | Negative  |
|   |  Positive | 72 | 0  |
|   |  Negative | 8 | 49  |

Discrepant s (ng/mL):

|  GC/MS | GC/MS | GC/MS | Dimension  |
| --- | --- | --- | --- |
|  253 | 47.2 | 300 | 95  |
|  311 | < lod | 311 | 240  |
|  326 | < lod | 326 | 189  |
|  313 | < lod | 313 | 240  |
|  363 | < lod | 363 | 204  |
|  255 | 67.3 | 322 | 271  |
|  275 | 70.2 | 345 | 278  |
|  279 | 71 | 350 | 296  |

&lt; lod: less than the limit of detection, &lt; 25 ng/mL

Method Comparison (cutoff = 500 ng/mL)

129 urine specimens were tested with the AMPH Flex® cartridge on the Dimension® system (cutoff = 500 ng/mL) and with the Syva® Emit® LL Plus Amphetamine Assay (9C309UL) on the Syva 30R® Biochemical System (cutoff = 500 ng/mL). All 129 specimens were also analyzed by GC/MS. Positives by GC/MS were determined by using the newly proposed SAMSHA guidelines by following the criteria of ≥ 250 ng/mL methamphetamine and ≥ 100 ng/mL amphetamine or ≥ 250 ng/mL amphetamine regardless of methamphetamine concentration. 28 of these had total amphetamines by GC/MS within 25% of the 500 ng/mL. Results are summarized in the tables below:

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|  AMPH Flex® Reagent Cartridge on the Dimension® clinical chemistry system (cutoff 500 ng/mL) |  | Syva 30R® Biochemical System (cutoff 500 ng/mL)  |   |
| --- | --- | --- | --- |
|   |   | Positive | Negative  |
|   |  Positive | 43 | 0  |
|   |  Negative | 1 | 85  |

Discrepant s (ng/mL):

|  GC/MS | GC/MS | Dimension | Syva  |
| --- | --- | --- | --- |
|  Meth | Amph | AMPH | 30R  |
|  556 | 62.7 | 405 | 598  |

&lt; lod: less than the limit of detection, &lt; 25 ng/mL

|  AMPH Flex® Reagent Cartridge on the Dimension® clinical chemistry system (cutoff 500 ng/mL) |  | GC/MS (cutoff ≥250 ng/mL amphetamine or ≥ 250 ng/mL methamphetamine and ≥ 100 ng/mL amphetamine)  |   |
| --- | --- | --- | --- |
|   |   | Positive | Negative  |
|   |  Positive | 34 | 9  |
|   |  Negative | 5 | 81  |

Discrepant s (ng/mL):

|  GC/MS | GC/MS | Dimension  |
| --- | --- | --- |
|  Meth | Amph | AMPH  |
|  410 | 36.7 | 550  |
|  506 | 43.6 | 572  |
|  513 | 44.8 | 564  |
|  528 | 47.9 | 572  |
|  561 | 48.6 | 507  |
|  577 | 50.5 | 574  |
|  514 | 56.1 | 534  |
|  495 | 58.4 | 548  |
|  598 | 64.5 | 561  |
|  286 | 169 | 366  |
|  281 | 173 | 388  |
|  254 | 174 | 344  |
|  300 | 179 | 398  |
|  315 | 186 | 393  |

&lt; lod: less than the limit of detection, &lt; 25 ng/mL

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Method Comparison (cutoff = 1000 ng/mL)

169 urine specimens were tested with the AMPH Flex® cartridge on the Dimension® system (cutoff = 1000 ng/mL) and with the Syva® Emit® LL Plus Amphetamine Assay (9C309UL) on the Syva 30R® Biochemical System (cutoff = 1000 ng/mL). Total amphetamine and methamphetamine values by GC/MS were reported for these 169 specimens. Positives by confirmation were determined according to the SAMSHA requirements by following the criteria of ≥ 500 ng/mL methamphetamine and ≥ 200 ng/mL amphetamines or ≥ 500 ng/mL amphetamines regardless of methamphetamine concentration.

Separate amphetamine and methamphetamine values were available for only 129 of these 169 specimens. Since separate amphetamine and methamphetamine values are required for confirmation testing according to SAMSHA guidelines, only those 129 samples were represented in the box plot shown in Table 10. Of these 129, there were 9 which had total amphetamines by GC/MS within 25% of the 1000 ng/mL cutoff. Results are summarized in the tables below:

|  AMPH Flex® Reagent Cartridge on the Dimension® clinical chemistry system (cutoff 1000 ng/mL) |  | Syva 30R® Biochemical System (cutoff 1000 ng/mL)  |   |
| --- | --- | --- | --- |
|   |   | Positive | Negative  |
|   |  Positive | 62 | 0  |
|   |  Negative | 2 | 105  |

Discrepant s (ng/mL):

|  GC/MS | GC/MS | Dimension | Syva  |
| --- | --- | --- | --- |
|  Meth | Amph | AMPH | 30R  |
|  713 | 534 | 929 | 1134  |
|  494 | 844 | 922 | aar  |

aar; above assay range, &gt; 2000 ng/mL

|  AMPH Flex® Reagent Cartridge on the Dimension® clinical chemistry system (cutoff 1000 ng/mL) |  | GC/MS (cutoff ≥500 ng/mL amphetamine or ≥ 500 ng/mL methamphetamine and ≥ 200 ng/mL amphetamine)  |   |
| --- | --- | --- | --- |
|   |   | Positive | Negative  |
|   |  Positive | 16 | 6  |
|   |  Negative | 8 | 99  |

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Discrepant s (ng/mL):

|  GC/MS | GC/MS | Dimension  |
| --- | --- | --- |
|  Meth | Amph | AMPH  |
|  1223 | 118 | 1264  |
|  1209 | 127 | 1347  |
|  1112 | 172 | 1395  |
|  1183 | 174 | 1314  |
|  1213 | 177 | 1414  |
|  1194 | 180 | 1367  |
|  631 | 202 | 627  |
|  652 | 214 | 375  |
|  713 | 534 | 929  |
|  496 | 615 | 682  |
|  390 | 624 | 681  |
|  333 | 635 | 648  |
|  494 | 844 | 922  |
|  161 | 1032 | 770  |

b. Matrix comparison: Not applicable

3. Clinical studies:
a. Clinical sensitivity: Not applicable
b. Clinical specificity: Not applicable.
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off: Analytical characterization of performance around the cut-off was demonstrated in the precision studies.

5. Expected values/Reference range: Not applicable.

N. Conclusion:

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K040133](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K040133)

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