← Product Code [DIS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS) · K033885

# BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) (K033885)

_Lin-Zhi International, Inc. · DIS · May 19, 2004 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K033885

## Device Facts

- **Applicant:** Lin-Zhi International, Inc.
- **Product Code:** [DIS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS.md)
- **Decision Date:** May 19, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3150
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone. benzodiazepines, and propoxyphene drugs. . The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not its its is is is is drug is present. The assay is solely intended for the qualitative screening of human writer for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene druation on mourvis designed for professional use with a number of automated clinical chemistry arralyzes. The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. The assay will not identify which drug is present in the positive urine sample. All screening positive samples shall subject to minist assays to identify the drug in the sample before alternative confirmation. Gas chromations withings spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, when preliminary positive results are used.

## Device Story

Ready-to-use, liquid reagent, homogeneous enzyme immunoassay; detects barbiturates, methadone, benzodiazepines, and propoxyphene in human urine. Principle: competition between drug-labeled G6PDH enzyme and free drug in sample for fixed antibody; absence of free drug allows antibody binding to labeled enzyme, decreasing activity. Enzyme activity measured spectrophotometrically at 340 nm via conversion of NAD to NADH; drug concentration proportional to enzyme activity. Used in clinical laboratories; operated by trained technicians/professionals. Provides preliminary qualitative screening results; positive samples require confirmatory testing (GC/MS). Assists healthcare providers in identifying potential drug use for clinical decision-making.

## Clinical Evidence

No clinical studies performed. Evidence consists of bench testing including precision (within-run and between-run), analytical sensitivity, and cross-reactivity. Method comparison study evaluated 180 samples (100 negative, 80 positive) against GC/MS and predicate devices. Results showed 100% agreement among positives and varying agreement among negatives (85-95%) when stratified by GC/MS values. Samples near cutoff were included.

## Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagents. Sensing principle: spectrophotometric measurement of G6PDH enzyme activity at 340 nm. Cutoffs: 200 ng/mL (secobarbital), 300 ng/mL (methadone), 200 ng/mL (oxazepam), 300 ng/mL (propoxyphene). Designed for use on automated clinical chemistry analyzers.

## Regulatory Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

## Special Controls

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

- LZI Barbiturate Enzyme Immunoassay ([K032764](/device/K032764.md))
- LZI Methadone Enzyme Immunoassay ([K023317](/device/K023317.md))
- LZI Benzodiazepine Enzyme Immunoassay ([K032365](/device/K032365.md))
- LZI Propoxyphene Enzyme Immunoassay ([K023795](/device/K023795.md))

## Submission Summary (Full Text)

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

A. 510(k) Number:
K033885

B. Purpose for Submission:
New Device

C. Analyte:
Barbiturates, methadone, benzodiazepines, and propoxyphene

D. Type of Test:
Qualitative enzyme immunoassay

E. Applicant:
Lin-Zhi International, Inc.

F. Proprietary and Established Names:
Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP)
Multiple Analyte Enzyme Immunoassay

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.3150 (Barbiturate test system)
21 CFR § 862.3620 (Methadone test system)
21 CFR § 862.3170 (Benzodiazepine test system)
21 CFR § 862.3700 (Propoxyphene test system)
2. Classification:
All Class II
3. Product Code:
DIS (Barbiturate test system)
DJR (Methadone test system)
JXM (Benzodiazepine test system)
JXN (Propoxyphene test system)
4. Panel:
Toxicology (91)

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

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

The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL cutoff for barbiturates (as secobarbital), 300 ng/mL cutoff for methadone, 200 ng/mL cutoff for benzodiazepines (as oxazepam), and 300 ng/mL cutoff for propoxyphene in human urine. 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 barbiturates, methadone, benzodiazepines, or propoxyphene. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) 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 BMBP 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 methadone calibrators only. The sponsor recommends that when the BMBP assay produces a positive result, the sample be retested with individual assays for barbiturates, methadone, benzodiazepines, or propoxyphene. 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.

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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.

**I. 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 drug (conjugate).

**J. Substantial Equivalence Information:**

1. **Predicate device name(s):**

LZI Barbiturate Enzyme Immunoassay
LZI Methadone Enzyme Immunoassay
LZI Benzodiazepine Enzyme Immunoassay
LZI Propoxyphene Enzyme Immunoassay

2. **Predicate K number(s):**

K032764
K023317
K032365
K023795

3. **Comparison with predicate**

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

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

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Methodology | Qualitative | Qualitative and semi-quantitative  |
|  Barbiturates cutoff | 200 ng/mL | 200 or 300 ng/mL  |
|  Methadone cutoff | Same | 300 ng/mL  |
|  Benzodiazepines cutoff | 200 ng/mL | 200 or 300 ng/mL  |
|  Propoxyphene cutoff | Same | 300 ng/mL  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Assay Type | Qualitative | Qualitative and semi-quantitative  |
|  Reagent | Antibodies to secobarbital, methadone, oxazepam, AND propoxyphene | Antibodies to secobarbital, methadone, oxazepam, OR propoxyphene  |
|  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 | Barbiturates: 50 ng/mL
Methadone: 75 ng/mL
Benzodiazepines: 25 ng/mL
Propoxyphene: 50 ng/mL | Barbiturates: 25 ng/mL
Methadone: 15 ng/mL
Benzodiazepines: 15 ng/mL
Propoxyphene: 7.5 ng/mL  |

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

The sponsor referenced the following guidance document(s) in their submission:

Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff, published December 2003.

The sponsor indicated deviation from this guidance in regards to interference testing.

## L. Test Principle:

The test is an enzyme immunoassay for use on automated clinical chemistry analyzers. The BMBP assay is calibrated with the LZI Methadone 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

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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.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

(All performance was established on the Hitachi 717 analyzer.)

Samples used for the precision study were the zero calibrator, cutoff calibrator, high calibrator, low control, and high control for barbiturates, methadone, benzodiazepines, or propoxyphene. For within-run precision, the study was conducted by one operator and was completed in one day. Each analyte and concentration was run 21 times and the assay was calibrated with each analytical run.

For between-run precision, the study lasted three weeks and involved two operators. Each analyte was run once per day for four consecutive working days for the first week, and repeated for the next two weeks. The assay was calibrated with each analytical run. Results of the studies are presented below.

Qualitative Precision - Barbiturates

|  Sample concentration, ng/mL | Mean mA/min | SD | CV% |  | Mean mA/min | SD | CV%  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Within-Run |  |  |  | Between-Run |  |  |   |
|  0 | 598.8 | 3.52 | 0.59 | 0 | 600.0 | 5.31 | 0.88  |
|  100 | 625.2 | 5.53 | 0.88 | 100 | 624.4 | 2.63 | 0.42  |
|  200 | 659.9 | 5.52 | 0.84 | 200 | 653.3 | 4.18 | 0.64  |
|  300 | 679.2 | 5.47 | 0.81 | 300 | 681.2 | 5.70 | 0.84  |
|  1000 | 722.9 | 3.79 | 0.52 | 1000 | 726.5 | 6.53 | 0.90  |

Qualitative Precision - Methadone

|  Sample concentration, ng/mL | Mean mA/min | SD | CV% |  | Mean mA/min | SD | CV%  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Within-Run |  |  |  | Between-Run |  |  |   |
|  0 | 596.3 | 4.27 | 0.72 | 0 | 600.3 | 5.94 | 0.99  |
|  225 | 638.5 | 5.77 | 0.90 | 225 | 640.0 | 5.45 | 0.85  |
|  300 | 657.3 | 3.80 | 0.58 | 300 | 658.7 | 4.29 | 0.65  |
|  375 | 673.2 | 4.06 | 0.60 | 375 | 673.3 | 5.30 | 0.79  |
|  1000 | 715.6 | 5.30 | 0.74 | 1000 | 707.3 | 5.00 | 0.71  |

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Qualitative Precision - Benzodiazepines

|  Sample concentration, ng/mL | Mean mA/min | SD | CV% |  | Mean mA/min | SD | CV%  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Within-Run |  |  |  | Between-Run |  |  |   |
|  0 | 602.1 | 3.83 | 0.64 | 0 | 600.8 | 4.96 | 0.83  |
|  100 | 635.7 | 3.55 | 0.56 | 100 | 637.6 | 4.21 | 0.66  |
|  200 | 655.9 | 4.45 | 0.68 | 200 | 655.6 | 4.53 | 0.69  |
|  300 | 683.7 | 4.65 | 0.68 | 300 | 683.0 | 5.31 | 0.78  |
|  1000 | 736.1 | 5.52 | 0.75 | 1000 | 739.0 | 7.04 | 0.95  |

Qualitative Precision - Propoxyphene

|  Sample concentration, ng/mL | Mean mA/min | SD | CV% |  | Mean mA/min | SD | CV%  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Within-Run |  |  |  | Between-Run |  |  |   |
|  0 | 600.5 | 5.19 | 0.86 | 0 | 599.5 | 4.2 | 0.70  |
|  225 | 642.5 | 5.48 | 0.85 | 225 | 642.1 | 4.3 | 0.67  |
|  300 | 656.8 | 5.54 | 0.84 | 300 | 657.7 | 4.8 | 0.73  |
|  375 | 671.8 | 4.84 | 0.72 | 375 | 671.4 | 6.3 | 0.94  |
|  3000 | 702.5 | 5.30 | 0.75 | 3000 | 707.5 | 2.5 | 0.35  |

Precision Study Results Around the Cutoff

|   |  | Barbiturates |  | Methadone |   |
| --- | --- | --- | --- | --- | --- |
|  Cutoff Rate (mA/min) |   | 632.7 |   | 656.3  |   |
|  Cutoff Concentration |   | 200 ng/mL |   | 300 ng/mL  |   |
|  Concentration of sample, ng/mL | Replicate | Rate (mA/min) | Result | Rate (mA/min) | Result  |
|  Spiked near cutoff - 25% | 1 | 615.6 | Neg | 628.8 | Neg  |
|   |  2 | 624.3 | Neg | 628.4 | Neg  |
|   |  3 | 622.5 | Neg | 636.4 | Neg  |
|   |  4 | 621.6 | Neg | 623.2 | Neg  |
|   |  5 | 626.6 | Neg | 625.2 | Neg  |
|  Spiked near cutoff + 25% | 1 | 641.2 | Pos | 660.7 | Pos  |
|   |  2 | 646.8 | Pos | 664.1 | Pos  |
|   |  3 | 639.6 | Pos | 668.9 | Pos  |
|   |  4 | 644.8 | Pos | 667.9 | Pos  |
|   |  5 | 640.8 | Pos | 658.9 | Pos  |

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|   |  | Benzodiazepines |  | Propoxyphene |   |
| --- | --- | --- | --- | --- | --- |
|  Cutoff Rate (mA/min) |   | 634.5 |   | 657.9  |   |
|  Cutoff Concentration |   | 200 ng/mL |   | 300 ng/mL  |   |
|  Concentration of sample, ng/mL | Replicate | Rate (mA/min) | Result | Rate (mA/min) | Result  |
|  Spiked near cutoff – 25% | 1 | 620.9 | Neg | 628.0 | Neg  |
|   |  2 | 616.4 | Neg | 612.7 | Neg  |
|   |  3 | 622.5 | Neg | 622.1 | Neg  |
|   |  4 | 621.8 | Neg | 615.9 | Neg  |
|   |  5 | 622.3 | Neg | 632.2 | Neg  |
|  Spiked near cutoff + 25% | 1 | 644.0 | Pos | 675.0 | Pos  |
|   |  2 | 645.5 | Pos | 676.1 | Pos  |
|   |  3 | 644.5 | Pos | 687.6 | Pos  |
|   |  4 | 647.0 | Pos | 680.9 | Pos  |
|   |  5 | 650.6 | Pos | 682.0 | Pos  |

b. Linearity/assay reportable range
Not applicable. The assay is intended for qualitative use.

c. Traceability (controls, calibrators, or method):
Calibrators and commercial control materials are specified in the labeling but are not supplied in the kit. Calibrators were cleared under 510K K023317 and controls were cleared under 510Ks K032764, K023317, K032365, and K023795

d. Detection limit:
Sensitivity of the assay is reported as follows:

Barbiturates: 50 ng/mL
Methadone: 75 ng/mL
Benzodiazepines: 25 ng/mL
Propoxyphene: 50 ng/mL

To determine analytical sensitivity, the sponsor assayed the negative calibrator 10 times within the same run and extrapolated the value of each measurement from the standard curve. The average and standard deviation of those readings was calculated. The analytical sensitivity was estimated by adding 2 standard deviations to the average of the readings.

e. Analytical specificity:
Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into drug-free urine calibrator matrix. By analyzing various concentration of each compound the

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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 with the targeted compound listed first:

Barbiturates

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Secobarbital | 200  |
|  Phenobarbital | 400  |
|  Butalbital | 470  |
|  Pentobarbital | 650  |
|  Allobarbital | 1000  |
|  Amobarbital | 2000  |
|  Aprobarbital | 450  |
|  Barbital | 7000  |
|  Butabarbital | 800  |
|  Cyclopentobarbital | 250  |
|  Thiopental | 1300  |

Benzodiazepines

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Oxazepam | 200  |
|  Alprazolam | 75  |
|  Bromazepam | 2100  |
|  Chlordiazepoxide | 65  |
|  Clobazam | 750  |
|  Clonazepam | 65  |
|  Diazepam | 80  |
|  Flunitrazepam | 50  |
|  Flurazepam | 90  |
|  Lormetazepam | 50  |
|  Lorazepam | 90  |
|  Medazepam | 23  |
|  Nitrazepam | 150  |
|  Norfludiazepam | 15  |
|  Prazepam | 75  |
|  Temazepam | 80  |
|  Triazolam | 45  |
|  Oxazepam-glururonide | >10,000  |
|  Lorazepam-glucuronide | >10,000  |
|  Temazepam-glucuronide | >10,000  |

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## Methadone

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Methadone | 300  |
|  6-Dimethylamino-4,4-diphenyl-3-heptanol
acetate hydrochloride (LAAM.HCl) | 10,000  |
|  (-) a-Methadol.HCl | 8,000  |

## Propoxyphene

|  Compound | Response equivalent to cutoff in ng/mL  |
| --- | --- |
|  Propoxyphene | 300  |
|  Norpropoxyphene | 620  |

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 BMBP assay.

|  Potential Cross-reactant | Concentration (μg/mL)  |
| --- | --- |
|  Acetaminophen | 1000  |
|  Acetylsalicylic Acid | 1000  |
|  Amitriptyline | 50  |
|  Amphetamine | 1000  |
|  Benzoylecgonine | 1000  |
|  Bupropion | 1000  |
|  Caffeine | 1000  |
|  Chlorpheniramine | 15  |
|  Chlorpromazine | 20  |
|  Cocaine | 400  |
|  Codeine | 1000  |
|  Dextromethorphan | 50  |
|  Ecgonine | 1000  |
|  Ephedrine | 1000  |
|  Imipramine | 20  |
|  Lidocaine | 1000  |
|  Meperidine | 600  |
|  Methamphetamine | 1000  |
|  Methaqualone | 1000  |
|  Morphine | 1000  |

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|  Potential Cross-reactant | Concentration (μg/mL)  |
| --- | --- |
|  Nortriptyline | 50  |
|  Phencyclidine | 1000  |
|  Promethazine | 1000  |
|  Ranitidine | 1000  |
|  Secobarbital | 1000  |
|  Valproic Acid | 1000  |

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.

f. Assay cut-off:
The Substance Abuse and Mental Health Services Administration (SAMHSA) has not recommended cutoff concentrations for the analytes in this assay.

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

2. Comparison studies:

a. Method comparison with predicate device:

A total of 180 samples (100 negative and 80 positive) were evaluated by the candidate device and by GC/MS and/or the predicate device.

Sample description: Unaltered clinical urine samples were evaluated. 110 additional diluted samples were also included in the study. The 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.

Sample selection: Twenty of the negative samples were analyzed by the candidate device and the predicate devices only. The positive samples and the remaining negative samples were analyzed by the candidate device and the predicate devices and are traceable to a GC-MS concentration.

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

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Number of study sites: one

Description of the site(s): Manufacturer's facility

Type of study site: Manufacturer's staff

Operator description: Manufacturer's staff

Number of instruments used: One

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

|   | Positive by Predicate Devices | Negative by Predicate Devices  |
| --- | --- | --- |
|  Positive by Candidate Device | 80 | 7*  |
|  Negative by Candidate Device | 0 | 93  |

% Agreement among positives is 92%

% Agreement among negatives is 100%

* Samples were grouped based on their concentration of barbiturates, methadone, benzodiazepines, or propoxyphene. Within each group, analytes other than the targeted dug were found:

Benzodiazepine group – one negative sample was found to contain methadone

Methadone group – two negative samples were found to contain benzodiazepines

Barbiturate group – one negative sample was found to contain benzodiazepines and two negative samples were found to contain both methadone and benzodiazepines

Propoxyphene group – one negative sample was found to contain benzodiazepines.

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# Candidate Device Results vs. stratified GC/MS Values - Barbiturates

|  Candidate Device Results | 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* | 2† | 12 | 8  |
|  Negative | 2 | 15 | 0 | 0  |

GC/MS values used to categorize samples in this table are determined by analyzing concentrations for secobarbital, butabarbital, and phenobarbital and calculating a final concentration based on their relative cross-reactivities to the BMBP assay.

*sample was found to contain benzodiazepines
†samples were found to contain methadone and benzodiazepines

% Agreement among positives is 100%
% Agreement among negatives is 85%

# Candidate Device Results vs. stratified GC/MS Values - Methadone

|  Candidate Device Results | 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 | 2* | 13 | 7  |
|  Negative | 3 | 15 | 0 | 0  |

GC/MS values used to categorize samples in this table are based on the concentration of methadone found in the sample.

* samples were found to contain benzodiazepines

% Agreement among positives is 100%
% Agreement among negatives is 90%

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# Candidate Device Results vs. stratified GC/MS Values - Benzodiazepines

|  Candidate Device Results | 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* | 13 | 6  |
|  Negative | 1 | 19 | 0 | 0  |

GC/MS values used to categorize samples in this table are determined by analyzing concentrations for clonazepam, alprazolam, oxazepam, lorazepam, and temazepam and calculating a final concentration based on their relative cross-reactivities to the BMBP assay.

*sample was found to contain methadone

% Agreement among positives is 100%
% Agreement among negatives is 95%

# Candidate Device Results vs. stratified GC/MS Values - Propoxyphene

|  Candidate Device Results | 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 | 15 | 5  |
|  Negative | 5 | 14 | 0 | 0  |

GC/MS values used to categorize samples in this table are determined by analyzing concentrations for propoxyphene and norpropoxyphene and calculating a final concentration based on their relative cross-reactivities to the BMBP assay.

*sample was found to contain benzodiazepines

% Agreement among positives is 100%
% Agreement among negatives is 95%

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

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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:
Barbiturates, methadone, benzodiazepines, and propoxyphene should not be present in the urine of persons who have not taken these drugs.

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

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K033885](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K033885)

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