CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)

K033866 · Lin-Zhi International, Inc. · DIO · Apr 7, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033866
• Device Name: CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
• Applicant: Lin-Zhi International, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with 300 ng/mL cutoff for cocaine metabolite, 1000 ng/mL cutoff for amphetamines, 300 ng/mL cutoff for opiates, and 25 ng/mL cutoff for phencyclidine. The assay will produce a positive result if any of the four analytes are present at a concentration at or above their respective cutoffs but will not identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method for the individual drugs must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. The device is for in vitro diagnostic use. It is intended for prescription use only.

Device Story

Ready-to-use, liquid reagent, homogeneous enzyme immunoassay for qualitative screening of human urine. Input: human urine sample. Principle: competitive binding between drug-labeled glucose-6-phosphate dehydrogenase (G6PDH) and free drug in sample for fixed amount of specific antibody. Absence of free drug allows antibody to bind labeled drug, inhibiting G6PDH activity; presence of free drug results in higher enzyme activity. Output: spectrophotometric measurement at 340 nm (NAD to NADH conversion). Used in clinical laboratories by professional staff on automated chemistry analyzers. Results aid diagnosis and treatment of drug use; preliminary positive results require confirmatory testing via GC/MS or HPLC.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated over 11 days. Method comparison study (n=170) against GC/MS and predicate devices showed 100% agreement for cocaine and phencyclidine, 95% for amphetamines, and 94% for opiates. Analytical specificity and cross-reactivity established via spiking studies.

Technological Characteristics

Homogeneous enzyme immunoassay; reagents include monoclonal/polyclonal antibodies, substrate, and enzyme-labeled drug conjugates. Measures absorbance at 340 nm on automated clinical chemistry analyzers (e.g., Hitachi 717). Qualitative output. No specific materials or software algorithm class stated.

Indications for Use

Indicated for qualitative screening of human urine for cocaine metabolite, amphetamines, opiates, and phencyclidine in individuals suspected of drug use. Provides preliminary analytical results; requires confirmation by alternative chemical methods (e.g., GC/MS). For professional use on automated clinical chemistry analyzers.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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

• Cocaine Metabolite Enzyme Immunoassay (k020763)
• Amphetamines Enzyme Immunoassay (k020369)
• Opiate Enzyme Immunoassay (k020368)
• Phencyclidine Enzyme Immunoassay (k020254)

Submission Summary (Full Text)

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

A. 510(k) Number:
k033866

B. Analyte:
Benzoylecgonine, amphetamine, opiates, and phencyclidine

C. Type of Test:
Qualitative enzyme immunoassay

D. Applicant:
Lin-Zhi International, Inc.

E. Proprietary and Established Names:
CAMP – Cocaine Metabolite – Amphetamines – Opiate – Phencyclidine – Multiple
Analyte Enzyme Immunoassay

F. Regulatory Information:

Regulation section:
21 CFR § 862.3250 (Cocaine and cocaine metabolite test system)
21 CFR § 862.3650 (Opiate test system)
21 CFR § 862.3100 (Amphetamine test system)

Classification:
Class II

1. Product Code:
DIO (Cocaine and cocaine metabolite test system)
DJG (Opiate test system)
DKZ (Amphetamine test system)
LCM (Phencyclidine test system)

2. Panel:
Toxicology (91)

G. Intended Use:

1. Intended use(s):
Refer to Indications for use.

2. Indication(s) for use:
The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple
Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with
300 ng/mL cutoff for cocaine metabolite, 1000 ng/mL cutoff for
amphetamines, 300 ng/mL cutoff for opiates, and 25 ng/mL cutoff for

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phencyclidine. The assay will produce a positive result if any of the four analytes are present at a concentration at or above their respective cutoffs but will not identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method for the individual drugs must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The device is for in vitro diagnostic use. It is intended for prescription use only.

3. Special condition for use statement(s):

The LZI CAMP Assay provides only a preliminary analytical test result. A positive result indicates that one or more of the four analytes may be present in the sample. In addition, since the assay is designed to detect multiple analytes, it is possible that if two or more analytes are present at concentrations below their respective cutoffs, a positive result will be produced. The performance of this assay has been validated using the LZI opiate calibrators only. The sponsor recommends that when the CAMP assay produces a positive result, the sample be retested with individual assays for cocaine metabolite, amphetamines, opiates, and phencyclidine. Following this testing, 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.

The assay is not designated for use in point-of-care settings.

Tests for opiates cannot distinguish between abused drugs and certain prescribed medications.(e.g., morphine, codeine)

Certain foods or medications may interfere with tests for amphetamines and opiates and cause false positive results.

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4. Special instrument Requirements:
The device is for use on automated clinical chemistry analyzers. Instruments should be capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing reactions, measuring at 340 nm, and performing standard curve calculations.

Performance was demonstrated in this submission on the Hitachi 717 analyzer.

H. Device Description:
The device consists of two wet reagents which contain the key components of the immunoassay; a mixture of monoclonal and polyclonal antibodies against the drugs, substrate, and enzyme-labeled drugs (conjugates).

I. Substantial Equivalence Information:

1. Predicate device name(s):
Cocaine Metabolite Enzyme Immunoassay
Amphetamines Enzyme Immunoassay
Opiate Enzyme Immunoassay
Phencyclidine Enzyme Immunoassay

2. Predicate K number(s):
k020763
k020369
k020368
k020254

3. Comparison with predicate:
The CAMP assay is designed to detect all four analytes listed above with a single reagent. The four predicate devices and the CAMP assay are for use on automated analyzers.

The reagent formulations vary between the new device and the predicate devices.

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Methodology | Homogeneous enzyme immunoassay | Same |
| Benzoylecgonine cutoff | 300 ng/mL | Same |
| Amphetamines cutoff | 1000 ng/mL | Same |
| Opiates cutoff | 300 ng/mL | Same |
| Phencyclidine cutoff | 25 ng/mL | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Assay Type | Qualitative | Qualitative and semi-quantitative |
| Reagent | Antibodies to benzoylecgonine, amphetamines, opiates, AND phencyclidine | Antibodies to benzoylecgonine, amphetamines, opiates, OR phencyclidine |
| Controls | 8 per run: negative and positive for each of the four analytes | 2 per run: negative and positive for the specific analyte |
| Calibrators | 3 per run: negative, cutoff, and high | 5 per run: negative, low, cutoff, intermediate, and high for the specific analyte |
| Sensitivity | Benzoylecgonine: 50 ng/mL
Amphetamines: 100 ng/mL
Opiates: 50 ng/mL
Phencyclidine: 3 ng/mL | Benzoylecgonine: 4 ng/mL
Amphetamines: 30 ng/mL
Opiates: 15 ng/mL
Phencyclidine: 1 ng/mL |

J. Standard/Guidance Document Referenced (if applicable):
The sponsor referenced the following guidance document(s) in the submission: Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff, published December 2003.

K. Test Principle:
The test is an enzyme immunoassay for use on automated clinical chemistry analyzers. The CAMP assay is calibrated with the LZI Opiate Calibrators, at concentrations of 0, 300, and 1000 ng/mL. Enzyme-labeled drug and drug present in the sample compete for limited antibody binding sites. Binding of the enzyme-labeled drug inhibits its reaction with the substrate, thereby influencing the rate of absorbance change measured by the instrument. The rate of absorbance change is proportional to the concentration of drug in the sample. Concentrations of controls and unknowns are calculated from the standard curve.

Results are read at 340 nm.

L. Performance Characteristics (if/when applicable):
Analytical performance:
Precision/Reproducibility:

Samples used for the precision study were the zero calibrator, cutoff calibrator, high calibrator, low control, and high control for cocaine, amphetamines, opiates, and phencyclidine. The study was conducted by one operator using one lot of reagent over eleven days. The assay was calibrated with each analytical run. For within-run precision, each analyte was run 21 times on one day. For between-

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run precision, each analyte was run once on day one, then one run per day over the next ten days. Results of the studies are presented below.

Qualitative Precision – Cocaine Metabolite

| Sample concentration, ng/mL | Mean mA/min | SD | CV% | | Mean mA/min | SD | CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Within-Run | | | | Between-Run | | | |
| 0 | 736.3 | 5.49 | 0.75 | 0 | 742.4 | 3.54 | 0.48 |
| 225 | 786.2 | 5.09 | 0.65 | 225 | 793.4 | 5.13 | 0.65 |
| 300 | 803.6 | 7.70 | 0.96 | 300 | 806.9 | 4.43 | 0.55 |
| 375 | 811.9 | 7.02 | 0.86 | 375 | 822.1 | 7.02 | 0.85 |
| 3000 | 876.8 | 5.33 | 0.61 | 3000 | 882.3 | 5.46 | 0.62 |

Qualitative Precision – Amphetamines

| Sample concentration, ng/mL | Mean mA/min | SD | CV% | | Mean mA/min | SD | CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Within-Run | | | | Between-Run | | | |
| 0 | 734.7 | 6.23 | 0.85 | 0 | 742.4 | 3.54 | 0.48 |
| 750 | 793.0 | 6.44 | 0.81 | 750 | 792.8 | 4.30 | 0.54 |
| 1000 | 804.0 | 4.86 | 0.60 | 1000 | 799.0 | 3.78 | 0.47 |
| 1250 | 810.2 | 5.94 | 0.73 | 1250 | 808.9 | 6.14 | 0.76 |
| 2000 | 825.5 | 5.73 | 0.69 | 2000 | 828.4 | 3.31 | 0.40 |

Qualitative Precision – Opiates

| Sample concentration, ng/mL | Mean mA/min | SD | CV% | | Mean mA/min | SD | CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Within-Run | | | | Between-Run | | | |
| 0 | 736.0 | 6.62 | 0.90 | 0 | 742.4 | 3.54 | 0.48 |
| 225 | 782.4 | 7.20 | 0.92 | 225 | 793.0 | 6.45 | 0.81 |
| 300 | 801.8 | 7.35 | 0.92 | 300 | 809.1 | 4.55 | 0.56 |
| 375 | 817.5 | 6.35 | 0.78 | 375 | 819.8 | 3.05 | 0.37 |
| 1000 | 878.7 | 5.85 | 0.67 | 1000 | 886.0 | 6.15 | 0.69 |

Qualitative Precision – Phencyclidine

| Sample concentration, ng/mL | Mean mA/min | SD | CV% | | Mean mA/min | SD | CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Within-Run | | | | Between-Run | | | |
| 0 | 735.1 | 6.16 | 0.84 | 0 | 742.4 | 3.54 | 0.48 |
| 18 | 789.6 | 6.14 | 0.78 | 18 | 794.1 | 5.03 | 0.63 |
| 25 | 799.2 | 5.24 | 0.66 | 25 | 804.9 | 5.11 | 0.63 |

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| 32 | 809.3 | 7.01 | 0.87 | 32 | 814.0 | 4.63 | 0.57 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 100 | 833.5 | 6.33 | 0.76 | 100 | 829.1 | 4.68 | 0.56 |

Precision Study Results Around the Cutoff

| | | COC | | AMP | |
| --- | --- | --- | --- | --- | --- |
| Cutoff Rate (mA/min) | | 812.3 | | 813.2 | |
| Cutoff Concentration | | 300 ng/mL | | 1000 ng/mL | |
| Concentration of sample, ng/mL | Replicate | Rate (mA/min) | Result | Rate (mA/min) | Result |
| Spiked near cutoff - 25% | 1 | 803.8 | Neg | 797.5 | Neg |
| | 2 | 808.0 | Neg | 806.6 | Neg |
| | 3 | 800.7 | Neg | 801.3 | Neg |
| | 4 | 809.0 | Neg | 789.4 | Neg |
| | 5 | 803.6 | Neg | 807.6 | Neg |
| Spiked near cutoff + 25% | 1 | 829.7 | Pos | 825.3 | Pos |
| | 2 | 826.4 | Pos | 821.2 | Pos |
| | 3 | 821.5 | Pos | 820.3 | Pos |
| | 4 | 820.4 | Pos | 818.2 | Pos |
| | 5 | 827.3 | Pos | 817.9 | Pos |
| | | OP | | PCP | |
| --- | --- | --- | --- | --- | --- |
| Cutoff Rate (mA/min) | | 816.6 | | 817.0 | |
| Cutoff Concentration | | 300 ng/mL | | 25 ng/mL | |
| Concentration of sample, ng/mL | Replicate | Rate (mA/min) | Result | Rate (mA/min) | Result |
| Spiked near cutoff - 25% | 1 | 807.6 | Neg | 804.4 | Neg |
| | 2 | 803.3 | Neg | 802.7 | Neg |
| | 3 | 798.9 | Neg | 799.5 | Neg |
| | 4 | 805.3 | Neg | 808.4 | Neg |
| | 5 | 800.2 | Neg | 804.6 | Neg |
| Spiked near cutoff + 25% | 1 | 837.0 | Pos | 830.2 | Pos |
| | 2 | 826.6 | Pos | 831.5 | Pos |
| | 3 | 843.6 | Pos | 824.0 | Pos |
| | 4 | 825.8 | Pos | 832.3 | Pos |
| | 5 | 848.7 | Pos | 820.6 | Pos |

Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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Traceability (controls, calibrators, or method):

Calibrators and commercial control materials are specified in the labeling but are not supplied in the kit. The calibrators were previously cleared under premarket notification K020368. Controls were cleared under K020763, K020369, K020368, and K020254.

Detection limit:

Sensitivity of the assay to the four analytes is as follows:

Cocaine metabolite – 50 ng/mL
Amphetamine/Methamphetamine – 100 ng/mL
Opiates – 50 ng/mL
Phencyclidine – 3 ng/mL

To determine analytical sensitivity, the sponsor assayed the zero calibrator 10 times within the same run and calculated the average and standard deviation of those readings in mA/min. Two standard deviations were then added to the average of the readings. This represented the sponsor’s estimate of the absorbance rate corresponding to the analytical sensitivity of the assay. The estimated absorbance rate was then compared to the measured absorbance rate of the proposed sensitivity for that analyte. If the estimated absorbance rate was less than the measured absorbance rate, the sensitivity of the assay was considered to be less than or equal to the concentrations listed above.

Analytical specificity:

Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into the zero calibrator. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table(s) below:

Amphetamine/Methamphetamine

| Drug Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| d-amphetamine | 1000 |
| l-amphetamine | Neg up to 24,000 ng/mL |
| d-methamphetamine | 1000 |
| l-methamphetamine | Neg up to 10,000 ng/mL |
| D,L 3,4-Methylenedioxymethamphetamine (MDMA) | 2500 |
| 3,4-Methylenedioxyamphetamine (MDA) | 2800 |

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## Opiates

| Drug compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Codeine | 150 |
| Norcodeine | 7000 |
| Hydrocodone | 300 |
| Hydromorphone | 600 |
| Oxycodone | 2000 |
| Thebaine | 400 |
| Oxymorphone | 6000 |
| Morphine | 300 |
| Morphine-3-β-glucuronide | 625 |
| Morphine-6-β-glucuronide | 550 |
| Dihydrocodeine | 400 |
| Levorphanol | 600 |

## Cocaine

| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Benzoylecogonine | 300 |
| Cocaine | 30,000 |
| Norcocaine | 60,000 |
| Ecgonine Methyl Ester | 350,000 |

## Phencyclidine

| Phencyclidine | 25 |
| --- | --- |

The following compounds were evaluated for potential positive interference with the assay. To evaluate for interference test compounds were spiked into the drug-free calibrator at various concentrations listed below. None of the compounds on the list caused a positive result with the CAMP assay.

| Compounds | Conc. (ug/ml) | X-reactivity |
| --- | --- | --- |
| Acetaminophen | 1500 | Negative |
| Acetylsalicyclic Acid | 1500 | Negative |
| Albuterol | 3000 | Negative |
| Amitriptyline | 50 | Negative |
| l-Amphetamine | 24 | Negative |
| Amobarbital | 1000 | Negative |
| Benzobetamine | 2000 | Negative |
| Bromopheniramine | 100 | Negative |
| Bupropion | 1000 | Negative |
| Buspirone | 3000 | Negative |
| Caffeine | 100 | Negative |
| Chlorpheniramine | 50 | Negative |
| Chlorpromazine | 80 | Negative |
| Clomipramine | 30 | Negative |
| Cycloazocine | 300 | Negative |
| Desipramine | 130 | Negative |
| Dextromethorphan | 40 | Negative |
| Diphenhydramine | 100 | Negative |
| Doxepin | 175 | Negative |

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| d,l-Enhedrine | 700 | Negative |
| --- | --- | --- |
| Fenfluramine | 7 | Negative |
| Fentanyl | 3000 | Negative |
| Fluoxetine | 800 | Negative |
| Fluphenazine | 3000 | Negative |
| Isoxuprine | 3000 | Negative |
| Imipramine | 20 | Negative |
| Ketamine | 100 | Negative |
| Lidocaine | 1000 | Negative |
| Maprotiline | 600 | Negative |
| Meperidine | 25 | Negative |
| Methadone | 1000 | Negative |
| Mepentermine | 50 | Negative |
| Methanyrilene | 300 | Negative |
| Metronidazole | 700 | Negative |
| Nalbuphine | 3000 | Negative |
| Nicotine | 800 | Negative |
| Norpropoxyphene | 100 | Negative |
| Nortriptyline | 100 | Negative |
| Oxazepam | 1000 | Negative |
| Phendimetrazine | 300 | Negative |
| Phenethylamine | 40 | Negative |
| Phenmetrazine | 75 | Negative |
| Phenobarbital | 1000 | Negative |
| Phenothiazine | 100 | Negative |
| Phentermine | 40 | Negative |
| Phenylephrine | 500 | Negative |
| d- | | Negative |
| Phenylpropanolamine | 2500 | |
| d,l- | | Negative |
| Phenylpropanolamine | 500 | |
| l- | | Negative |
| Phenylpropanolamine | 240 | |
| Primidone | 1000 | Negative |
| Procainamide | 800 | Negative |
| Promethazine | 100 | Negative |
| Propoxyphene | 260 | Negative |
| Propranolol | 100 | Negative |
| d-Pseudoephedrine | 250 | Negative |
| l-Pseudoephedrine | 2500 | Negative |
| Ranitidine | 800 | Negative |
| Scopolamine | 3000 | Negative |
| Secobarbital | 1000 | Negative |
| Sertraline | 1000 | Negative |
| Thioridazine | 70 | Negative |
| Tramadol | 1000 | Negative |
| Trazodone | 2900 | Negative |
| Trifluoperazine | 3000 | Negative |
| Triflupromazine | 3000 | Negative |
| Triprolidine | 150 | Negative |
| Tyramine | 600 | Negative |
| Valproic Acid | 1000 | Negative |

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The sponsor did not evaluate the effects of pH, specific gravity, or albumin on the assay.

There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.

## Assay cut-off:

The identified cutoff concentrations of the assays are recommended for use by the Substance Abuse and Mental Health Services Administration (SAMHSA), except for the opiate assay.

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above.

## Comparison studies:

### Method comparison with predicate device:

Samples previously analyzed by GC-MS were selected to be analyzed by the candidate device. Some samples were prepared by diluting clinical samples with high drug concentrations with drug-free urine. This was done in order to obtain samples near the cutoff concentration of the assay, because the sponsor was not able to obtain unaltered samples near the cutoff.

For the method comparison studies, the following sample groups were selected, for a total of $n = 170$.

- Benzoylecgonine group: 40 samples
- Amphetamines group: 40 samples
- Opiates group: 32 samples
- Phencyclidine group: 38 samples
- Negative for all analytes: 20 samples

The BE, AMP, OP, and PCP samples were analyzed by the candidate device and predicate devices and are traceable to GC-MS concentrations. The samples negative for all analytes were analyzed by the candidate device and the predicate devices only.

The study included an adequate number of samples that contained drugs near to the cutoff concentration of the assay. More than $10\%$ of the study samples are evenly distributed between plus and minus $50\%$ of the claimed cutoff concentration of each analyte.

The study was performed at the manufacturer's facility by the manufacturer's staff.

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Candidate Device Results vs. Predicate Device Results (four analytes)

| | Positive by Predicate Devices | Negative by Predicate Devices |
| --- | --- | --- |
| Positive by Candidate Device | 75 | 0 |
| Negative by Candidate Device | 0 | 95 |

Agreement among positives is 100%
Agreement among negatives is 100%

Candidate Device Results vs. stratified GC/MS Values Benzoylecgonine

| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 12 | 8 |
| Negative | 6 | 14 | 0 | 0 |

Agreement among positives is 100%
Agreement among negatives is 100%

Candidate Device Results vs. stratified GC/MS Values Amphetamines

| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 1 | 11 | 8 |
| Negative | 5 | 14 | 1 | 0 |

Agreement among positives is 95%
Agreement among negatives is 95%

Candidate Device Results vs. stratified GC/MS Values Opiates

| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 1 | 0 | 9 | 6 |
| Negative | 2 | 13 | 1 | 0 |

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Agreement among positives is 94%; Agreement among negatives is 94%
Candidate Device Results vs. stratified GC/MS Values
Phencyclidine

| Candidate Device Results | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 12 | 7 |
| Negative | 5 | 14 | 0 | 0 |

Agreement among positives is 100%
Agreement among negatives is 100%

GC/MS values used to categorize samples in these tables are based on:
- Cocaine group: benzoylecgonine only
- Amphetamines group: sum of amphetamine and methamphetamine
- Opiates group: sum of morphine, codeine, and hydromorphone
- Phencyclidine group: phencyclidine only

Matrix comparison:
Not applicable. The assay is intended for only one sample matrix.

3. Clinical studies:
a. Clinical sensitivity:
Not applicable. Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

M. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.