(271 days)
One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:
Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 50 ng/ml.
Cocaine (COC) Benzoylecgonine 300 ng/ml.
Amphetamine (AMP) D-Amphetamine 1000 ng/ml.
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 2000 (MOP) Morphine 2000 ne/ml.
The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.
These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
The provided document describes the performance of the Co-Innovation Biotech Co., Ltd. One Step Single/Multi-drug Test Cup and Dipcard for the qualitative detection of drugs and drug metabolites in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance metrics (like sensitivity, specificity, or agreement percentages). Instead, it presents the results of clinical studies (accuracy studies) designed to demonstrate the device's performance against a gold standard (GC/MS). The implied acceptance is that the device demonstrates a high level of agreement with GC/MS, especially near and above the cutoff concentrations.
For the purpose of this response, I infer the performance target is to achieve high agreement with GC/MS. The reported device performance is shown in the tables below, demonstrating the number of positive and negative results from the device compared to GC/MS at different concentration levels.
Performance Summary (based on provided data for both formats: Cup and Dipcard)
| Drug Test | Cut-off Level (ng/mL) | Device Format | Agreement with Drug Free (Negative Result) | Agreement with < Half Cutoff (Negative Result) | Agreement Near Cutoff Negative | Agreement Near Cutoff Positive | Agreement High Positive (Positive Result) | Number of Discordant Results (Device Pos/GCMS Neg or Device Neg/GCMS Pos) |
|---|---|---|---|---|---|---|---|---|
| AMP | 1000 | Single Test Cup | 100% (117/117) | Not explicitly given in a clear format (combined into one cell) | 11/12 (Negatives) | 10/11 (Positives) | 31/31 (Positives) | 2 (1 Positive at 867 ng/mL, 1 Negative at 1175 ng/mL) |
| AMP | 1000 | Single Test Dipcard | 100% (117/117) | 100% (7/7) | 11/12 (Negatives) | 10/11 (Positives) | 29/29 (Positives) | 2 (1 Positive at 867 ng/mL, 1 Negative at 1175 ng/mL) |
| AMP | 1000 | Multi-drug Test Cup | 100% (25/25) | 100% (3/3) | 11/12 (Negatives) | 10/11 (Positives) | 29/29 (Positives) | 2 (1 Positive at 867 ng/mL, 1 Negative at 1175 ng/mL) |
| AMP | 1000 | Multi-drug Test Dipcard | 100% (25/25) | 100% (3/3) | 11/12 (Negatives) | 10/11 (Positives) | 29/29 (Positives) | 2 (1 Positive at 867 ng/mL, 1 Negative at 1175 ng/mL) |
| COC | 300 | Single Test Cup | 100% (133/133) | 100% (0/0) | 12/13 (Negatives) | 0/0 (Positives) | 31/31 (Positives) | 1 (1 Positive at 172 ng/mL) |
| COC | 300 | Single Test Dipcard | 100% (133/133) | 100% (0/0) | 12/13 (Negatives) | 9/9 (Positives) | 31/31 (Positives) | 1 (1 Positive at 172 ng/mL) |
| COC | 300 | Multi-drug Test Cup | 100% (27/27) | 100% (0/0) | 12/13 (Negatives) | 9/9 (Positives) | 31/31 (Positives) | 1 (1 Positive at 172 ng/mL) |
| COC | 300 | Multi-drug Test Dipcard | 100% (27/27) | 100% (0/0) | 12/13 (Negatives) | 9/9 (Positives) | 31/31 (Positives) | 1 (1 Positive at 172 ng/mL) |
| THC | 50 | Single Test Cup | 100% (107/107) | 100% (4/4) | 9/10 (Negatives) | 12/13 (Positives) | 31/31 (Positives) | 2 (1 Positive at 40 ng/mL, 1 Negative at 59 ng/mL) |
| THC | 50 | Single Test Dipcard | 100% (107/107) | 100% (4/4) | 9/10 (Negatives) | 12/13 (Positives) | 31/31 (Positives) | 2 (1 Positive at 40 ng/mL, 1 Negative at 59 ng/mL) |
| THC | 50 | Multi-drug Test Cup | 100% (26/26) | 100% (4/4) | 9/10 (Negatives) | 12/13 (Positives) | 27/27 (Positives) | 2 (1 Positive at 40 ng/mL, 1 Negative at 59 ng/mL) |
| THC | 50 | Multi-drug Test Dipcard | 100% (26/26) | 100% (4/4) | 9/10 (Negatives) | 12/13 (Positives) | 27/27 (Positives) | 2 (1 Positive at 40 ng/mL, 1 Negative at 59 ng/mL) |
| MET | 1000 | Single Test Cup | 100% (85/85) | 100% (4/4) | 13/14 (Negatives) | 17/18 (Positives) | 44/44 (Positives) | 2 (1 Positive at 904 ng/mL, 1 Negative at 1248 ng/mL) |
| MET | 1000 | Single Test Dipcard | 100% (85/85) | 100% (4/4) | 13/14 (Negatives) | 17/18 (Positives) | 44/44 (Positives) | 2 (1 Positive at 904 ng/mL, 1 Negative at 1248 ng/mL) |
| MET | 1000 | Multi-drug Test Cup | 100% (24/24) | 100% (2/2) | 13/14 (Negatives) | 12/13 (Positives) | 27/27 (Positives) | 2 (1 Positive at 904 ng/mL, 1 Negative at 1248 ng/mL) |
| MET | 1000 | Multi-drug Test Dipcard | 100% (24/24) | 100% (2/2) | 13/14 (Negatives) | 12/13 (Positives) | 27/27 (Positives) | 2 (1 Positive at 904 ng/mL, 1 Negative at 1248 ng/mL) |
| MOP | 2000 | Single Test Cup | 100% (67/67) | 100% (5/5) | 15/17 (Negatives) | 19/19 (Positives) | 57/57 (Positives) | 2 (2 Positives at 1608 ng/mL and 1875 ng/mL) |
| MOP | 2000 | Single Test Dipcard | 100% (67/67) | 100% (5/5) | 15/17 (Negatives) | 19/19 (Positives) | 57/57 (Positives) | 2 (2 Positives at 1608 ng/mL and 1875 ng/mL) |
| MOP | 2000 | Multi-drug Test Cup | 100% (21/21) | 100% (2/2) | 15/17 (Negatives) | 11/11 (Positives) | 29/29 (Positives) | 2 (2 Positives at 1608 ng/mL and 1875 ng/mL) |
| MOP | 2000 | Multi-drug Test Dipcard | 100% (21/21) | 100% (2/2) | 15/17 (Negatives) | 11/11 (Positives) | 29/29 (Positives) | 2 (2 Positives at 1608 ng/mL and 1875 ng/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Single Drug Test:
- Test Set Size: 165-186 clinical urine specimens for each drug (AMP, COC, THC, MET, MOP) were used for each device format (Cup and Dipcard).
- Data Provenance: The specimens were described as "clinical urine specimens," implying they were collected from human subjects in a real-world clinical setting. No specific country of origin is mentioned, but the submitter's address is in Guangzhou, P.R. China, suggesting the data may originate there. The study appears to be retrospective, as existing clinical specimens were analyzed.
- Multi-Drug Test:
- Test Set Size: 80 clinical urine specimens for each drug were used for each device format (Cup and Dipcard).
- Data Provenance: Similar to the single drug test, these were "clinical urine specimens." Provenance details are identical to the single drug test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). This is a laboratory-based analytical method, not a human expert interpretation. Therefore, the concept of "number of experts" or their "qualifications" in the context of establishing ground truth does not apply as it would for image-based diagnostics. The accuracy of GC/MS itself is well-established as a confirmatory method for drug testing.
4. Adjudication Method for the Test Set
No human adjudication method (like 2+1, 3+1 consensus) was used. The study compared the device results directly against the quantitative results obtained from GC/MS. Discordant results (where the device and GC/MS disagreed) are individually listed with the specific drug concentration from GC/MS. This suggests that GC/MS was considered the definitive gold standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is a biochemical assay (lateral flow immunoassay) for qualitative detection, not an AI-assisted diagnostic tool where human readers interpret medical images or data. The device provides a direct positive/negative result, not an interpretation that humans would then review.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this was effectively a standalone study. The device (One Step Single/Multi-drug Test Cup/Dipcard) itself produces a result (qualitative positive or negative) without human interpretation. The study evaluates the performance of the device only against the GC/MS ground truth. Human involvement is limited to performing the test procedure and reading the physical test line, which is a direct visual cue, not an interpretive task that would significantly affect the "algorithm's" performance.
7. The Type of Ground Truth Used
The ground truth used was GC/MS Analysis (Gas Chromatography/Mass Spectrometry). This is an objective, analytical method that provides quantitative drug concentrations in the urine specimens. It is considered the gold standard for drug confirmation.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the device. As an immunochromatographic assay, these devices are typically developed through bench-top experimentation and optimization of reagents and manufacturing processes, rather than machine learning training that would require a distinct "training set." The performance data provided is for the rigorous testing of the finalized device.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit training set mentioned in the context of machine learning, this question is not directly applicable. The development and optimization of the immunoassay itself would rely on established biochemical principles and analytical methods to determine antigen-antibody reactions and cutoff sensitivities, likely using reference standards and known concentrations of drugs and metabolites during the R&D phase.
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JAN 15 2014
Section 5 - 510(k) Summary
Date of Summary Preparation: 12/30/2013
1. Submitter's Identifications
Submitter: Co-Innovation Biotech Co., Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285
- Correspondent's Identifications
Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@l26.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285
3. Name of the Device
Recommended classification regulation;
| 21 CFR 862.3100 |
|---|
| 21 CFR 862.3610 |
| 21 CFR 862.3250 |
| 21 CFR 862.3870 |
| 21 CFR 862.3640 |
Device class: Class II Panel: Toxicology (91) Product code: DKZ,DJC,DIO,LDJ,DK N Common Name:
Amphetamine Test System Methamphetamine Test System Cocaine Test System Cannabinoid Test System Morphine Test System
· Proprietary names:
One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard
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4. The Predicate Devices
UCP Home™ Drug Screening Test Cards UCP Home™ Drug Screening Test Cup
5. Device Description
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
6. Intended Use of Device
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 2000 (MOP) | Morphine | 2000 ng/mL |
The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
7. Comparison to Predicate Devices:
A summary comparison of features of the One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table:
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| Item | Device | Predicate (K091588) |
|---|---|---|
| Indication for use | Qualitative detection ofdrugs-of-abuse in urine(Cocaine, Morphine, Methamphetamine,Amphetamine,Marijuana ) | Same (but the number of drugsdetected different) |
| Intended Users | Prescription Use | Over the Counter (OTC) Useand Prescription Use |
| Specimen | Urine | Same |
| Cutoff | Cocaine:300 ng/mLMethamphetamine:1000 ng/mLAmphetamine:1000 ng/mLMorphine:2000 ng/mLMarijuana:50 ng/mL | Cocaine:300 ng/mLMethamphetamine:1000 ng/mLAmphetamine:1000 ng/mLMorphine:300 ng/mLMarijuana:50 ng/mL |
| Read time | 5 minutes | Same |
| Storage | 4 ~ 30 °C | 2 ~ 30 °C |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateralflow immunochromatographicassay based on the principle ofantigen antibodyimmunochemistry | Same |
| Configuration | Dipcard and Cup | Card and Cup |
Remark:
-
- The subject devices have all features of the predicate device except the number of drugs detected, the cutoff of Morphine and storage temperature condition different. These differences do not affect the performance characteristics of the subject devices.
8. Performance Data:
Accuracy
Single drug Test:
165-186 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:
| DrugTest | Result | Co-Innovation Drug free by GC/MSanalysis | Less than half thecutoff concentrationby GC/MS analysis | Near Cutoff Negative(Between 50% below thecutoff and the cutoffconcentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total | |
|---|---|---|---|---|---|---|---|---|
| 0010 | ਨੇੜੇ | 176 | ||||||
| AMP | 117 | 11 | 0 | |||||
| + | 0 | 0 | ರು | 31 | 186 | |||
| COC | 133 | 0 | 12 | O | 0 | |||
| 1200 | 31 | 165 | ||||||
| THC | 107 | এ | 0 | O |
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|---|---|---|---|---|---|---|---|
| 00 | 165 | ||||||
| MET | 25 | 11 | |||||
| 1) | |||||||
| MOP | r | 15 | 165 |
Analysis of Discordant Results with One Step Single drug Test Cup .
| One Step Single drug Test Cup | GC/MS Analysis | |||
|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| · MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-A9-THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-A9-THC-9-COOH |
165-186 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:
| DrugTest | Co-InnovationResult | Drug free by GC/MSanalysis | Less than half thecutoff concentrationby GC/MS analysis | Near Cutoff Negative(Between 50% below thecutoff and the cutoffconcentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| AMP | + | 0 | 0 | 1 | 10 | 29 | 176 |
| AMP | - | 117 | 7 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 186 |
| COC | - | 133 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 31 | 165 |
| THC | - | 107 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 17 | 44 | 165 |
| MET | - | 85 | 4 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 19 | 57 | 165 |
| MOP | - | 67 | 5 | 15 | 0 | 0 |
| One Step Single drug Test Dipcard | GC/MS Analysis | |||
|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | DrugConcentration(ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9-THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9-THC-9-COOH |
Analysis of Discordant Results with One Step Single drug Test Dipcard
Multi-drug Test:
80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:
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| DrugTest | Co-InnovationResult | Drug free by GC/MSanalysis | Less than half thecutoff concentrationby GC/MS analysis | Near Cutoff Negative(Between 50% below thecutoff and the cutoffconcentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| AMP | + | 0 | 0 | 1 | 10 | 29 | 80 |
| - | 25 | 3 | 11 | 1 | 0 | ||
| COC | + | 0 | 0 | 1 | 9 | 31 | 80 |
| - | 27 | 0 | 12 | 0 | 0 | ||
| THC | + | 0 | 0 | 1 | 12 | 27 | 80 |
| - | 26 | 4 | 9 | 1 | 0 | ||
| MET | + | 0 | 0 | 1 | 12 | 27 | 80 |
| - | 24 | 2 | 13 | 1 | 0 | ||
| MOP | + | 0 | 0 | 2 | 11 | 29 | 80 |
| - | 21 | 2 | 15 | 0 | 0 |
Analysis of Discordant Results with One Step Multi-drug Test Cup
| One Step Multi-drug Test Cup | GC/MS Analysis | ||||
|---|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine | |
| AMP | 1000 | Positive | 867 | Amphetamine | |
| AMP | 1000 | Negative | 1175 | Amphetamine | |
| COC | 300 | Positive | 172 | Benzoylecgonine | |
| MET | 1000 | Positive | 904 | Methamphetamine | |
| MET | 1000 | Negative | 1248 | Methamphetamine | |
| MOP | 2000 | Positive | 1608 | Morphine | |
| MOP | 2000 | Positive | 1875 | Morphine | |
| THC | 50 | Positive | 40 | 11-nor-Δ9-THC-9-COOH | |
| THC | 50 | Negative | 59 | 11-nor-Δ9-THC-9-COOH |
80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:
| DrugTest | Co-InnovationResult | Drug free by GC/MSanalysis | Less than half thecutoff concentrationby GC/MS analysis | Near Cutoff Negative(Between 50% below thecutoff and the cutoffconcentration) | Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration) | High Positive(greater than 50%above the cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| AMP | + | 0 | 0 | 1 | 10 | 29 | 80 |
| - | 25 | 3 | 11 | 1 | 0 | ||
| COC | + | 0 | 0 | 1 | 9 | 31 | 80 |
| - | 27 | 0 | 12 | 0 | 0 | ||
| THC | + | 0 | 0 | 1 | 12 | 27 | 80 |
| - | 26 | 4 | 9 | 1 | 0 | ||
| MET | + | 0 | 0 | 1 | 12 | 27 | 80 |
| - | 24 | 2 | 13 | 1 | 0 | ||
| MOP | + | 0 | 0 | 2 | 11 | 29 | 80 |
| - | 21 | 2 | 15 | 0 | 0 |
| Analysis of Discordant Results with One Step Multi-drug Test Dipcard | ||
|---|---|---|
| ---------------------------------------------------------------------- | -- | -- |
| One Step Multi-drug Test Dipcard | GC/MS Analysis | |||
|---|---|---|---|---|
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9-THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9-THC-9-COOH |
05-5
.
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Other Information About Performance Characteristics:
The performance characteristics of One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard were evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard perform satisfactorily when used according to the package inserts.
10. Conclusion:
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are substantially equivalent to UCP Home™ Drug Screening Test Cards and UCP Home™ Drug Screening Test Cup. .
--- End of this section ---
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2014
CO-INNOVATION BIOTECH CO., LTD. HONG FENG, PRODUCT MANAGER NO. 13 YANYUAN ROAD. TIANHE DISTRICT GUANGZHOU, GUANGDONG 510507 CH
Re: K131110
Trade/Device Name: One Step Single/Multi-drug Test Cup; One Step Single Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJC, DKN, LDJ, DIO Dated: January 2, 2014 Received: January 2, 2014
Dear Hong Feng:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 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" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fcc.gov/mediabureau/radio/licensing/sourcesector1/radioindustry.html
Sincercly yours.
Courtney H. Lias -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131110
Device Name
One-Step Single/Multi-drug Test Cup; One-Step single/multi-drug Test Card
Indications for Use (Describe)
One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:
ી જિડા Marijuana (THC) Cocaine (COC) Amphetamine (AMP) Methamphetamine (MET) Morphine 2000 (MOP)
Calibrato r · Delta-9-THC-COOH Benzoylecgonine D-Amphetamine D-Methamphetamine Morphine
Cut-off level 50 ng/ml. 300 ng/ml. 1000 ng/ml. 1000 ng/mL 2000 ne/ml.
The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.
These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
§ 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).