CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

• K Number: K161251
• Device Name: CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
• Manufacturer: Hangzhou Clongene Biotech Co., Ltd
• Date Cleared: 2016-08-30 ( 119 days)
• Product Code: DKZ , DIO , JXM
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: K052115
• Predicate For: N/A

Intended Use

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Device Description

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies performed for the CLUNGENE drug tests, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with numerical thresholds for performance metrics. Instead, it presents various performance studies (Precision, Cut-off, Interference, Specificity, Method Comparison, and Lay-user studies) and concludes that the device's performance is "acceptable" and "substantially equivalent to the predicate."

However, we can infer the implied acceptance criteria from the reported results, particularly for the precision and comparison studies, which demonstrate high accuracy around the cutoff concentrations. Essentially, the criteria are met if the tests accurately identify negative samples as negative and positive samples as positive, especially around the cutoff values, with minimal false positives or negatives.

Implied Acceptance Criteria and Reported Performance Summary

Performance Metric	Implied Acceptance Criterion (Inferred from data)	Reported Device Performance (Summary)
Precision	Consistent and accurate results across different lots and concentrations, particularly around the cutoff. All samples below -25% cut-off should be negative, and all samples above +25% cut-off should be positive. Samples at cut-off and +/- 25% allow for some variability but still demonstrating general accuracy.	Amphetamine Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): For all three lots and all four formats, 100% correct results were observed for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive). At the exact cut-off concentration, results varied but showed a mix of positive and negative, confirming detection around the cut-off. Cocaine Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): Similar to Amphetamine, 100% correct results were consistently observed for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive) across all lots and formats. Variability in positive/negative calls occurred at the exact cut-off. Oxazepam Tests (Cassette, Dip Card, Split-Key Cup, Easy Cup): Consistently 100% correct results for concentrations at -100%, -75%, -50% cut-off (all negative) and +25%, +50%, +75%, +100% cut-off (all positive) across all lots and formats. Variability in positive/negative calls occurred at the exact cut-off.
Cut-off Verification	The device should correctly identify samples above the specified cut-off as positive and below as negative.	For Amphetamine, Cocaine, and Oxazepam, all results were positive at and above +25% Cut-off and all negative at and below -25% Cut-off. This confirms the functional cut-off.
Interference	No interference from common exogenous or endogenous substances that would lead to false positive or false negative results.	Numerous compounds (physiological and pathological conditions, common drugs) were tested at 100µg/mL. The document states, "Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices."
Specificity (Cross-reactivity)	Limited or no cross-reactivity with structurally similar compounds or other common substances at concentrations below relevant clinical levels.	Detailed tables provided for Amphetamine, Cocaine, and Oxazepam showing concentrations that cause a positive result. For instance, L-Amphetamine showed 2% cross-reactivity at 50000 ng/mL compared to D-Amphetamine's 100% at 1000 ng/mL. Similarly, other drugs (e.g., Alprazolam, Clonazepam for Oxazepam) showed varying degrees of cross-reactivity at higher concentrations. The levels are generally much higher than the detection levels for the target drug, indicating reasonable specificity.
Effect of Urine Specific Gravity and pH	Accurate results are maintained across a physiological range of urine specific gravity (1.000-1.035) and pH (4-9).	For samples spiked at +/- 25% of Cut-Off levels, all results were positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, regardless of specific gravity or pH. "No differences observed for different devices."
Method Comparison (Clinical)	High concordance with the GC/MS reference method, especially for samples clearly positive or negative, and reasonable performance around the cut-off.	Amphetamine, Cocaine, Oxazepam (all formats): High agreement with GC/MS. For "Negative", "Low Negative (-50%)" categories, all device results were negative for most viewers across all formats. For "High Positive (+50%)", all device results were positive. Discrepancies primarily occurred in the "Near Cutoff Negative" and "Near Cutoff Positive" ranges (e.g., a few false negatives or false positives just above/below the GC/MS cutoff). For example, Amphetamine Cassette Viewer A had 1 positive result in "Near Cutoff Negative" and 0 negative results in "Near Cutoff Positive", while Viewer B had 0 positive and 1 negative result respectively. This expected variability is seen across all drugs and device formats.
Lay-user Study	High percentage of correct results for clearly positive/negative samples when interpreted by lay users, and ease of understanding instructions.	Amphetamine, Cocaine, Oxazepam (all formats): All lay-user studies showed 100% correct results for -100%, -75%, -50% cut-off (negative) and +50%, +75% cut-off (positive). At -25% and +25% cut-off, accuracy ranged narrowly, typically between 90-95% (e.g., 1-2 incorrect results out of 20 samples), indicating high performance even at concentrations closest to the threshold. All lay users found the instructions easy to follow, and the package insert had a Flesch-Kincaid Grade Level of 7.

2. Sample Sizes and Data Provenance

• Precision Study:

  • Test Set Sample Size: For each drug (Amphetamine, Cocaine, Oxazepam) and each device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), 3 lots were tested. For each lot, 8 concentrations were tested (ranging from -100% cut off to +100% cut off). Each concentration was tested with 50 replicates (2 runs per day for 25 days).
  • Total (per drug per format): 3 lots * 8 concentrations * 50 replicates = 1200 tests.
  • Provenance: Samples were "prepared by spiking drug in negative samples." These were laboratory-prepared samples. The original "negative samples" are not specified as to country of origin, but the overall context of an FDA submission suggests the intent is for global marketability/regulatory compliance. This is a prospective lab study.

• Cut-off Verification Study:

  • Test Set Sample Size: 150 samples were used per drug/device type (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off).
  • Provenance: "prepared by spiking drug in negative samples." This is a prospective lab study.

• Interference Study:

  • Test Set Sample Size: Urine samples (drug-free and spiked with target drugs at -25% and +25% Cut-Off) were tested with 3 batches of each device for numerous potential interfering substances. Specific numbers per substance are not given, but refers to "summarized in the following tables" which list many compounds.
  • Provenance: Laboratory-prepared spiked urine samples. This is a prospective lab study.

• Specificity (Cross-reactivity) Study:

  • Test Set Sample Size: Not explicitly stated as a total number of samples, but "drug metabolites and other components" were tested using three batches of each device. Similar to interference, these were individual compounds tested for cross-reactivity.
  • Provenance: Laboratory-prepared samples. This is a prospective lab study.

• Effect of Urine Specific Gravity and pH Study:

  • Test Set Sample Size: Urine samples with varying specific gravity (1.000-1.035) or pH (4-9) were spiked with target drugs at -25% and +25% Cut-Off levels. These were tested using three lots of each device.
  • Provenance: Laboratory-prepared spiked urine samples. This is a prospective lab study.

• Method Comparison Studies (Clinical):

  • Test Set Sample Size: For each drug (Amphetamine, Cocaine, Oxazepam) and each device format, 80 unaltered clinical samples were used (40 negative and 40 positive).
  • Provenance: These were "unaltered clinical samples." The country of origin is not specified, but they are clearly retrospective samples (collected from a clinical setting).

• Lay-user Study:

  • Test Set Sample Size: 1680 lay persons participated. Each participant tested 1 blind-labeled sample. For each drug and each device format, there were 7 concentration levels tested (0, 75, 150, 225, 375, 450, 525 ng/mL corresponding to percentages of cutoff) with 20 samples per concentration level. So, 7 concentrations * 20 samples = 140 samples tested by lay users for each drug/device format.
  • Provenance: Urine samples were "prepared at the following concentrations... by spiking drug(s) into drug free-pooled urine specimens." The concentrations were confirmed by GC/MS. This makes them laboratory-prepared samples for a prospective lay-user study.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth for these studies was established by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate analytical chemistry technique considered the "gold standard" for confirming the presence and concentration of drugs in urine. It is an objective laboratory method and therefore does not rely on human experts for establishing ground truth in the same way imaging-based diagnostic tests might use radiologists.

• Method Comparison Studies: The ground truth for these studies was also established by GC/MS results. The document states, "The samples were blind labeled and compared to GC/MS results." For these studies, the device results were compared to the GC/MS results. The method comparison studies mention "three laboratory assistants" who ran the devices, but their role was to operate the device and record its output, not to establish the ground truth.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth was established by GC/MS, which is an objective chemical analysis. There was no human expert adjudication method (like 2+1, 3+1, etc.) needed or performed to establish the ground truth for these studies. The determination of positive/negative by the device was compared directly to the quantitative GC/MS value relative to the specified cut-off.

• Method Comparison Studies: The samples were "blind labeled and compared to GC/MS results." This implies a direct comparison, not an adjudication process involving multiple human readers of the ground truth. The "three laboratory assistants" were viewers of the device results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done in the sense of human readers interpreting the raw urine samples with and without AI assistance (the device) to assess an effect size.
• The "Method Comparison Studies" involved "three laboratory assistants" (viewers) interpreting the results of the device and comparing these to GC/MS. This is a multi-reader study of the device's output, not a study of human readers' improvement with AI (the device) versus without it. The device itself is an "immunochromatographic assay," not an AI algorithm in the typical sense of machine learning in medical imaging.

6. Standalone (Algorithm Only) Performance Study

• Yes, the device's performance is inherently a standalone performance. The "CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays..." which produce a visual result (a colored line or its absence). The studies detailed (Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH) all assess the performance of the device itself (the "algorithm" or immunoassay in this context) against a known standard (GC/MS concentrations). The method comparison and lay-user studies also evaluate how human operators read the device's standalone output.

7. Type of Ground Truth Used

• The primary ground truth used for all performance studies was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is an objective, highly accurate analytical chemistry method used to determine the exact concentration of the target drugs in the urine samples.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for an in vitro diagnostic (IVD) test, which is a immunoassay device, not a machine learning or AI algorithm in the common sense that requires a "training set" for model development. Therefore, there is no mention or requirement for a training set in this context. The device's "training" is inherent in its chemical design and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

• As stated in point 8, there is no "training set" for these immunochromatographic assays. The performance is determined by the specific reagents, antibodies, and manufacturing consistency.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

2016 August 30,

HANGZHOU CLONGENE BIOTECH CO., LTD C/O JESSE XIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K161251

Trade/Device Name: Clungene Amphetamine Tests, Clungene Cocaine Tests, Clungene Oxazepam Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIO, JXM Dated: July 22, 2016 Received: July 27, 2016

Dear Mr. Xia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161251

Device Name Clungene Amphetamine Tests Clungene Cocaine Tests Clungene Oxazepam Tests

Indications for Use (Describe)

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Email: [e-mail].

• 1. Date: August 29, 2016 Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China 3. Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: [phone]
• 4. Device Name: CLUNGENE Amphetamine Tests CLUNGENE Cocaine Tests CLUNGENE Oxazepam Tests

Classification:

Product Code	CFR #	Panel
DKZ	21 CFR, 862.3100 Amphetamine Test System	Toxicology
JXM	21 CFR, 862.3170 Benzodiazepine Test System	Toxicology
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology

5. Predicate Devices: K052115

The FIRST CHECK MULTI DRUG CUP Urine Test

6. Intended Use

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses: it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

• 7. Device Description
     The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
• 8. Substantial Equivalence Information
     A summary comparison of features of the CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests and CLUNGENE Oxazepam Tests and the predicate devices is provided in following tables.

Item	Device	Predicate - K052115
Indication(s) for Use	For the qualitative determination of drugs of abuse in human urine.	Same (but the number of drugs detected is different)
Calibrator	d-Amphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

Table 1: Features Comparison of CLUNGENE Amphetamine Tests and the Predicate Devices

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Table 2: Features Comparison of CLUNGENE Cocaine Tests and the Predicate Devices

Item	Device	Predicate - K052115
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator	Cocaine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

Table 3: Features Comparison of CLUNGENE Oxazepam Tests and the Predicate Devices

Item	Device	Predicate - K052115
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator	Oxazepam	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

9. Test Principle

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are rapid tests for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by

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immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoffconcentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

10. Performance Characteristics

• 1. Analytical Performance
  • a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.

Cassette
LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Dip Card
LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	19-/31+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Split-Key Cup
LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	31-/19+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup
LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	19-/31+	50+/0-	50+/0-	50+/0-	50+/0-

CLUNGENE Amphetamine Tests

Cassette

CLUNGENE Cocaine Tests

Cassette

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
---------------	------------------	-----------------	-----------------	----------------	---------	-----------------	-----------------	-----------------	------------------

{8}------------------------------------------------

Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Dip Card
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-
Split-Key Cup
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	32-/18+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	31-/19+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

CLUNGENE Oxazepam Tests

Cassette

	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
Cassette Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Dip Card Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Split-Key Cup Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-

{9}------------------------------------------------

Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
-------	--------	--------	--------	--------	---------	--------	--------	--------	--------

b. Linearity

Not applicable.

• c. Stability
  The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

• d. Cut-off
  A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine and Oxazepam. didata davia for the a

	The following cut-off values for the candidate devices have been verified.

Calibrator	Cut-off (ng/mL)
d-Amphetamine	1000
Cocaine	300
Oxazepam	300

e. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices.

Amphetamine:

4-Acetamidophenol	Diazepam	O-Hydroxyhippuric acid
(-)-Cotinine	Diclofenac	Oxalic acid
(-)-Isoproterenol	Diflunisal	Oxazepam
(-)-Y-Ephedrine	Digoxin	Oxolinic acid
(±)-Chlorpheniramine	Diphenhydramine	Oxycodone
(IR,2S)-(-)-Ephedrine	Doxylamine	Oxymetazoline
3-Hydroxytyramine	Ecgonine hydrochloride	Papaverine
Acetophenetidin	Ecgonine methylester	Penicillin-G
Acetylsalicylic acid	Erythromycin	Pentazocaine
Aminopyrine	Estrone-3-sulfate	Pentobarbital
Amitriptyline	Ethyl-p-aminobenzoate	Perphenazine
Amobarbital	Fenfluramine	Phencyclidine
Amoxicillin	Fenoprofen	Phenelzine
Ampicillin	Furosemide	Phenobarbital

{10}------------------------------------------------

Ascorbic acid	Gentisic acid	Phenylpropanolamine
Aspartame	Hemoglobin	Prednisolone
Atropine	Hydralazine	Prednisone
Benzilic acid	Hydrochlorothiazide	Procaine
Benzoic acid	Hydrocodone	Promazine
Benzoylecgonine	Hydrocortisone	Promethazine
Bilirubin	Ibuprofen	Quinidine
Brompheniramine	Imipramine	Quinine
Caffeine	Isoxsuprine	Ranitidine
Cannabidiol	Ketamine	Salicylic acid
Cannabinol	Ketoprofen	Secobarbital
Chloralhydrate	L-Ephedrine	Sulfamethazine
Chloramphenicol	L-Phenylephrine	Sulindac
Chlordiazepoxide	Labetalol	Temazepam
Chloroquine	Levorphanol	Tetracycline
Chlorothiazide	Loperamide	Tetrahydrocortisone
Chlorpromazine	Maprotiline	Tetrahydrozoline
Cholesterol	Meperidine	Thebaine
Clomipramine	Meprobamate	Thiamine
Clonidine	Methadone	Thioridazine
Cocaine hydrochloride	Methylphenidate	Tolbutamine
Codeine	Morphine-3-D-glucuronide	Triamterene
Cortisone	N-Acetylprocainamide	Trifluoperazine
Creatinine	Nalidixic acid	Trimethoprim
D-Norpropox yphene	Naloxone	Trimipramine
D-Propoxyphene	Naltrexone	Tryptamine
D/L-Octopamine	Naproxen	Uric acid
D/L-Propanolol	Niacinamide	Verapamil
D/L-Thyroxine	Nifedipine	Zomepirac
D/L-Tyrosine	Norcodeine	ß-Estradiol
Deoxycorticosterone	Norethindrone	49-THC-COOH
Dextromethorphan	Noscapine

Cocaine

Acetaminophen	Diflunisal	Oxazepam
(-)-Cotinine	Digoxin	Oxolinic acid
(-)-Ψ-Ephedrine	Diphenhydramine	Oxycodone
(±)-3,4-Methylenedioxyamphetamine	Doxylamine	Oxymetazoline
(±)-Brompheniramine	Ecgonine methylester	p-Hydroxymethamphetamine
(±)-Chlorpheniramine	Erythromycin	Papaverine
(±)-Isoproterenol	Estrone-3-sulfate	Penicillin-G
3-Hydroxytyramine	Ethyl-p-aminobenzoate	Pentobarbital
Acetophenetidin	Fenoprofen	Perphenazine
Acetylsalicylic acid	Furosemide	Phencyclidine
Aminopyrine	Gentisic acid	Phenelzine
Amitriptyline	Hemoglobin	Phenobarbital
Amobarbital	Hydralazine	Phentermine
Amoxicillin	hydrochloride	Phenylpropanolamine
Ampicillin	hydrochloride(±)-3,4-Methylene-dioxymethamphetamine	Prednisolone
Apomorphine	Hydrochlorothiazide	Prednisone
Aspartame	Hydrocodone	Procaine
Atropine	Hydrocortisone	Promazine
Benzilic acid	Ibuprofen	Promethazine
Benzoic acid	Imipramine	Quinidine
Benzphetamine	Iproniazid	Quinine
Caffeine	Isoxsuprine	Ranitidine
Cannabidiol	Ketamine	Salicylic acid
Cannabinol	Ketoprofen	Secobarbital
Chloralhydrate	L-Ascorbic acid	Serotonin
Chloramphenicol	L-Phenylephrine	Sulfamethazine
Chlordiazepoxide	Labetalol	Sulindac
Chloroquine	Levorphanol	Temazepam
Chlorothiazide	Loperamide	Tetracycline
Chlorpromazine	Maprotiline	Tetrahydrocortisone3 (β-D-glucuronide)
Cholesterol	Meperidine	Tetrahydrozoline
Clomipramine	Meprobamate	Thebaine
Clonidine	Methadone	Thiamine
Codeine	Methoxyphenamine	Thioridazine
Cortisone	Morphine Sulfate	Tolbutamide
Creatinine	Morphine-3-β-D-glucuronide	Triamterene
D-Norpropoxyphene	N-Acetylprocainamide	Trifluoperazine
D-Propoxyphene	Nalidixic acid	Trimethoprim
D-Pseudoephedrine	Naloxone	Trimipramine
D/L-Amphetamine Sulfate	Naltrexone	Tryptamine
D/L-Octopamine	Naproxen	Tyramine
D/L-Propranolol	Niacinamide	Uric acid
D/L-Tryptophan	Nifedipine	Verapamil
D/L-Tyrosine	Norcodeine	Zomepirac
Deoxycorticosterone	Norethindrone	ß-Estradiol
Dextromethorphan	Noscapine	β-Phenylethylamine
Diazepam	O-Hydroxyhippuric acid
Diclofenac	Oxalic acid

{11}------------------------------------------------

{12}------------------------------------------------

Oxazepam

4-Acetamidophenol	D-Propoxyphene	Naproxen
(-)-cotinine	D-Pseudoephedrine	Niacinamide
(-)-Y-Ephedrine	D/L-Amphetamine	Nifedipine
(+)-3,4-Methylenedioxy-amphetamine	D/L-Octopamine	Norethindrone
(+)-3,4-Methylenedioxy-methamphetamine	D/L-Propranolol	Noscapine
(±)-Chlorpheniramine	D/L-Tryptophan	O-Hydroxyhippuric acid
(±)-Chlorpheniramine	D/L-Tyrosine	Oxalic acid
(±)-Isoproterenol	Dextromethorphan	Oxolinic acid
3-Hydroxytyramine	Diclofenac	p-Hydroxy- methamphetamine
Acetophenetidin	Diflunisal	Pentobarbital
Acetylsalicylic acid	Digoxin	Perphenazine
Aminopyrine	Diphenhydramine	Phencyclidine
Amitriptyline	Doxylamine	Phenelzine
Amorbarbital	Ecgonine hydrochloride	Phenobarbital
Amoxicillin	Ecgonine methylester	Phentermine
Ampicillin	Fenoprofen	Phenylpropanolamine
Aporphine	Furosemide	Prednisone
Aspartame	Gentisic acid	Quinine
Atropine	Hemoglobin	Ranitidine
Benzilic acid	Hydrocortisone	Salicylic acid
Benzoic acid	Ibuprofen	Secobarbital
Benzoylecgonine	Imipramine	Serotonin (5-Hydroxytyramine)

{13}------------------------------------------------

Benzphetamine	Iproniazid	Sertraline
Bilirubin	Isoxsuprine	Sulfamethazine
Brompheniramine	Ketamine	Sulindac
Caffeine	Ketoprofen	Tetrahydrocortisone 3 ( β-D-glucuronide)
Caffeine	L-Ascorbic Acid	Tetrahydrozoline
Cannabidiol	L-Phenylephrine	Thiamine
Chloralhydrate	Labetalol	Thioridazine
Chloramphenicol	Loperamide	Tolbutamide
Chloroquine	Maprotiline	Triamterene
Chlorothiazide	Meperidine	Trifluoperazine
Chlorpromazine	Meprobamate	Trimethoprim
Cholesterol	Methadone	Tryptamine
Clomipramine	Methoxyphenamine	Tyramine
Clonidine	N-Acetylprocainamide	Uric acid
Cocaine hydrochloride	Nalidixic acid	Verapamil
Cortisone	Nalorphine	Zomepirac
Creatinine	Naloxone	β-Phenylethylamine
D-Norpropoxyphene	Naltrexone

f. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.

AMP

Drugs	Concentration (ng/ml)	% Cross Reactivity
D - Amphetamine	1000	100%
L - Amphetamine	50000	2%
D/L - Amphetamine	3000	33%
Phentermine	3000	33%
Hydroxyamphetamine	5000	20%
Methylenedioxyamphetamine (MDA)	5000	20%
3,4-methylenedioxy-methamphetamine (MDMA)	Negative at 100000	< 1%
Methylenedioxyethylamphetamine (MDE)	Negative at 100000	< 1%
D-methamphetamine	Negative at 100000	< 1%

{14}------------------------------------------------

L-methamphetamine	Negative at 100000	< 1%
Ephedrine	Negative at 100000	< 1%
Pseudoephedrine	Negative at 100000	< 1%

COC

Cocaine (COC)	Concentration(ng/ml)	% Cross-Reactivity
Benzoylecgonine	300	100
Cocaine HCl	780	38.5
Cocaethylene	12,500	2.4
Ecgonine HCl	32,000	0.9
Norcocaine	100,000	0.3

BZO

Drugs	Concentration (ng/ml)	% Cross Reactivity
Oxazepam	300	100%
Alprazolam	200	150%
a-Hydroxyalprazolam	1250	24%
Bromazepam	1500	20%
Chlordiazepoxide	1500	20%
Clobazam	100	300%
Clonazepam	800	37%
Clorazepate dipotassium	200	150%
Delorazepam	1500	20%
Desalkylflurazepam	400	75%
Diazepam	200	150%
Estazolam	2500	12%
Flunitrazepam	400	75%
Midazolam	12500	2%
Nitrazepam	100	300%
Norchlordiazepoxide	200	150%

{15}------------------------------------------------

Nordiazepam	400	75%
Temazepam	100	300%
Triazolam	2500	12%
D/L-Lorazepam	1500	20%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

2. Comparison Studies

Method comparison studies for the CLUNGENE Amphetamine Tests, the CLUNGENE Cocaine Tests and the CLUNGENE Oxazepam Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

Cassette		Negative	Low Negative by GC/MS(less than -50%)	Near Cutoff Negative by GC/MS(Between -50% and cutoff)	Near Cutoff Positive by GC/MS(Between the cutoff and +50%)	High Positive by GC/MS(greater than +50%)
Viewer A	Positive	0	0	1	20	20
Viewer A	Negative	10	15	14	0	0
Viewer B	Positive	0	0	0	19	20
Viewer B	Negative	10	15	15	1	0
Viewer C	Positive	0	0	0	18	20
Viewer C	Negative	10	15	15	2	0

Amphetamine

Discordant Results of Amphetamine Cassette

Viewer	Sample Number	GC/MS Result	CassetteViewer Results
Viewer A	AMP30	963	Positive
Viewer B	AMP59	1005	Negative
Viewer C	AMP59	1005	Negative
Viewer C	AMP78	1037	Negative

{16}------------------------------------------------

PanelDip		Negative	Low Negative byGC/MS(less than-50%)	Near Cutoff Negative byGC/MS(Between-50% andcutoff)	Near Cutoff Positive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	0	19	20
	Negative	10	15	15	1	0
ViewerB	Positive	0	0	0	18	20
	Negative	10	15	15	2	0
ViewerC	Positive	0	0	1	20	20
	Negative	10	15	14	0	0

Discordant Results of Amphetamine Panel Dip

Viewer	Sample Number	GC/MS Result	Panel DipViewer Results
Viewer C	AMP30	963	Positive
Viewer A	AMP59	1005	Negative
Viewer B	AMP59	1005	Negative
Viewer B	AMP78	1037	Negative

Split-KeyCup		Negative	Low Negativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	0	20	20
	Negative	10	15	15	0	0
ViewerB	Positive	0	0	1	19	20
	Negative	10	15	14	1	0
ViewerC	Positive	0	0	0	19	20
	Negative	10	15	15	1	0

Discordant Results of Amphetamine Split-Key Cup

Viewer	Sample Number	GC/MS Result	Split-Key CupViewer Results
Viewer B	AMP30	963	Positive
Viewer B	AMP59	1005	Negative
Viewer C	AMP59	1005	Negative

{17}------------------------------------------------

EasyCup		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	0	18	20
	Negative	10	15	15	2	0
ViewerB	Positive	0	0	1	19	20
	Negative	10	15	14	1	0
ViewerC	Positive	0	0	2	20	20
	Negative	10	15	13	0	0

Discordant Results of Amphetamine Easy Cup

Discordant Results of Amphetamine Easy Cup
Viewer	Sample Number	GC/MS Result	Easy Cup Viewer Results
Viewer B	AMP30	963	Positive
Viewer C	AMP30	963	Positive
Viewer C	AMP18	952	Positive
Viewer A	AMP59	1005	Negative
Viewer A	AMP78	1037	Negative
Viewer B	AMP59	1005	Negative

Cocaine

Cassette		Negative	Low Negative by GC/MS(less than -50%)	Near Cutoff Negative by GC/MS(Between -50% and cutoff)	Near Cutoff Positive by GC/MS(Between the cutoff and +50%)	High Positive by GC/MS(greater than +50%)
Viewer A	Positive	0	0	1	20	20
Viewer A	Negative	10	15	14	0	0
Viewer B	Positive	0	0	1	19	20
Viewer B	Negative	10	15	14	1	0
Viewer C	Positive	0	0	0	20	20
Viewer C	Negative	10	15	15	0	0

Discordant Results of Cocaine Cassette

Viewer	Sample Number	GC/MS Result	Cassette Viewer Results
Viewer A	COC45	284	Positive
Viewer B	COC45	284	Positive
Viewer B	COC66	307	Negative

{18}------------------------------------------------

PanelDip		Negative	Low Negative byGC/MS(less than-50%)	Near Cutoff Negative byGC/MS(Between-50% andcutoff)	Near Cutoff Positive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	2	20	20
	Negative	10	15	13	0	0
ViewerB	Positive	0	0	0	19	20
	Negative	10	15	15	1	0
ViewerC	Positive	0	0	0	19	20
	Negative	10	15	15	1	0

Discordant Results of Cocaine Panel Dip

Viewer	Sample Number	GC/MS Result	Panel DipViewer Results
Viewer B	COC35	311	Negative
Viewer C	COC35	311	Negative
Viewer A	COC16	296	Positive
Viewer A	COC45	284	Positive

Split-KeyCup		Negative	Low Negativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	0	20	20
	Negative	10	15	15	0	0
ViewerB	Positive	0	0	0	18	20
	Negative	10	15	15	2	0
ViewerC	Positive	0	0	1	20	20
	Negative	10	15	14	0	0

Discordant Results of Cocaine Split-Kev Cup
---------------------------------------------	--	--

Viewer	Sample Number	GC/MS Result	Split Cup Viewer Results
Viewer C	COC45	284	Positive
Viewer B	COC35	311	Negative
Viewer B	COC66	307	Negative

{19}------------------------------------------------

EasyCup		Negative	Low Negative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	0	18	20
	Negative	10	15	15	2	0
ViewerB	Positive	0	0	1	19	20
	Negative	10	15	14	1	0
ViewerC	Positive	0	0	0	19	20
	Negative	10	15	15	1	0

Discordant Results of Cocaine Easy Cup

Viewer	Sample Number	GC/MS Result	Easy CupViewer Results
Viewer B	COC45	284	Positive
Viewer A	COC35	311	Negative
Viewer A	COC66	307	Negative
Viewer B	COC66	307	Negative
Viewer C	COC35	311	Negative

Oxazepam

Cassette		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
Viewer	Positive	0	0	0	19	20
A	Negative	10	15	15	1	0
Viewer	Positive	0	0	1	19	20
B	Negative	10	15	14	1	0
Viewer	Positive	0	0	0	19	20
C	Negative	10	15	15	1	0

Discordant Results of Oxazepam Cassette

Viewer	Sample Number	GC/MS Result	CassetteViewer Results
Viewer B	BZ077	291	Positive
Viewer A	BZ013	309	Negative
Viewer B	BZO26	311	Negative
Viewer C	BZO61	308	Negative

{20}------------------------------------------------

PanelDip		Negative	Low Negative byGC/MS(less than-50%)	Near Cutoff Negative byGC/MS(Between-50% andcutoff)	Near Cutoff Positive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	19	20
ViewerA	Negative	10	15	14	1	0
ViewerB	Positive	0	0	0	20	20
ViewerB	Negative	10	15	15	0	0
ViewerC	Positive	0	0	1	20	20
ViewerC	Negative	10	15	14	0	0

Discordant Results of Oxazepam Panel Dip

Viewer	Sample Number	GC/MS Result	Panel DipViewer Results
Viewer A	BZO77	291	Positive
Viewer C	BZO57	298	Positive
Viewer A	BZO61	308	Negative

Split-KeyCup		Negative	Low Negativeby GC/MS(less than-50%)	Near CutoffNegativeby GC/MS(Between-50%and	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	18	20
ViewerA	Negative	10	15	14	2	0
ViewerB	Positive	0	0	1	18	20
ViewerB	Negative	10	15	14	2	0
ViewerC	Positive	0	0	0	19	20
ViewerC	Negative	10	15	15	1	0

Discordant Results of Oxazepam Split-Key Cup

Viewer	Sample Number	GC/MS Result	Split CupViewer Results
Viewer A	BZO57	298	Positive
Viewer B	BZO77	291	Positive
Viewer A	BZO26	311	Negative
Viewer A	BZO13	309	Negative
Viewer B	BZO26	311	Negative
Viewer B	BZO21	323	Negative
Viewer C	BZO61	308	Negative

{21}------------------------------------------------

Easy Cup	Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cutoff)	Near Cutoff Positive by GC/MS (Between the cutoff and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A Positive	0	0	1	18	20
Viewer A Negative	10	15	14	2	0
Viewer B Positive	0	0	2	18	20
Viewer B Negative	10	15	13	2	0
Viewer C Positive	0	0	1	19	20
Viewer C Negative	10	15	14	1	0

Discordant Results of Oxazepam Easy Cup
Viewer	Sample Number	GC/MS Result	Easy Cup Viewer Results
Viewer A	BZO57	298	Positive
Viewer B	BZO57	298	Positive
Viewer B	BZO77	291	Positive
Viewer B	BZO26	311	Negative
Viewer A	BZO61	308	Negative
Viewer A	BZO13	309	Negative
Viewer B	BZO13	309	Negative
Viewer C	BZO77	291	Positive
Viewer C	BZO26	311	Negative

Discordant Results of Oxazepam Easy Cup

Lay-user study

A lay user study was performed at three intended user sites with 1680 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested.

Comparison between GC/MS and Lay Person Results for Amphetamine Cassette

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	0	20	100%
+25% Cutoff	20	1250	19	1	95%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

{22}------------------------------------------------

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/MS (ng/mL)	Lay person results No. of Positive	Lay person results No. of Negative	The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	250	0	20	100
-50% Cutoff	20	500	0	20	100
-25% Cutoff	20	750	1	19	95
+25% Cutoff	20	1250	19	1	95%
+50% Cutoff	20	1500	20	0	100
+75% Cutoff	20	1750	20	0	100

Comparison between GC/MS and Lay Person Results for Amphetamine Split-Key Cup

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	2	18	90%
+25% Cutoff	20	1250	18	2	90%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

Comparison between GC/MS and Lay Person Results for Amphetamine Easy Cup

% of Cutoff	Numberofsamples	d-AmphetamineConcentration by GC/MS(ng/mL)	Lay person results		The percentageof correct results(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	1	19	95%
+25% Cutoff	20	1250	18	2	90%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

Comparison between GC/MS and Lay Person Results for Cocaine Cassette

% of Cutoff	Number of samples	Cocaine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative

{23}------------------------------------------------

-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Cocaine Dip Card

% of Cutoff	Numberofsamples	Cocaine Concentration byGC/MS (ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Cocaine Split-Key Cup

% of Cutoff	Number of samples	Cocaine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Cocaine Easy Cup

% of Cutoff	Numberofsamples	Cocaine Concentration byGC/MS (ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100

{24}------------------------------------------------

+75% Cutoff	20	525	20	0	100
-------------	----	-----	----	---	-----

Comparison between GC/MS and Lay Person Results for Oxazepam Cassette

% of Cutoff	Number of samples	Oxazepam Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	0	20	100
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Oxazepam Dip Card

% of Cutoff	Number of samples	Oxazepam Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	No. of Positive	No. of Negative	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	20	0	100
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Oxazepam Split-Key Cup

	Numberofsamples	Oxazepam Concentrationby GC/MS (ng/mL)	Lay person results		The
% of Cutoff			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	2	18	90%
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Oxazepam Easy Cup

% of Cutoff	Numberofsamples	Oxazepam Concentrationby GC/MS (ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100

{25}------------------------------------------------

-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	18	2	90
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

3. Clinical Studies

Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests and CLUNGENE Oxazepam Tests are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).