(106 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an immunoassay intended for the qualitative and semi-quantitative analysis of phencyclidine (PCP) in human urine for diagnostic purposes, not for treating or preventing disease.
Yes
The device is described as an immunoassay intended for qualitative and semi-quantitative analysis of phencyclidine in human urine, providing a preliminary analytical test result. This is a form of diagnostic testing.
No
The device description clearly states it is a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay," which is a chemical assay and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative analyses of phencyclidine (PCP) in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to provide diagnostic information (presence and approximate amount of PCP).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses "specific antibody" to detect phencyclidine in human urine. This is a common method used in IVD tests.
- Anatomical Site: The sample is "human urine," which is a biological specimen.
- Performance Studies and Key Metrics: The document describes performance characteristics like precision, sensitivity, accuracy, analytical recovery, and specificity, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K935320) indicates that this device is being compared to a previously cleared IVD device by a regulatory body like the FDA.
All these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Phencyclidine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of phencyclidine (PCP) in human urine.
The Phencyclidine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method 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-ofabuse test result, particularly when preliminary positive results are used.
Product codes
LCM
Device Description
LZI's Phencyclidine Enzyme Immunoassay is a ready-to-use, liguid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect phencyclidine in human urine with minimal cross-reactivity to various phencyclidine-related compounds and/or common drugs.
The assay is based on competition between phencyclidine labeled with enzyme glucose-6phosphate dehydrogenase (G6PDH), and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
LZI's Phencyclidine Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.
Key Metrics
Within Run Precision:
Qualitative:
Negative: Mean Rate 168.0, SD 0.68, % CV 0.41
18 ng/mL: Mean Rate 238.6, SD 1.16, % CV 0.49
25 ng/mL: Mean Rate 264.6, SD 1.19, % CV 0.45
32 ng/mL: Mean Rate 282.8, SD 1.42, % CV 0.50
100 ng/mL: Mean Rate 341.2, SD 0.73, % CV 0.21
Semi-quantitative:
Mean Recovery:
18 ng/mL: 17.4, SD 0.27, % CV 1.54
25 ng/mL: 24.7, SD 0.37, % CV 1.50
32 ng/mL: 31.6, SD 0.54, % CV 1.71
Run-To-Run Precision:
Qualitative:
Negative: Mean Rate 168.0, SD 0.90, % CV 0.54
18 ng/mL: Mean Rate 238.8, SD 0.55, % CV 0.23
25 ng/mL: Mean Rate 264.6, SD 0.79, % CV 0.30
32 ng/mL: Mean Rate 284.1, SD 0.87, % CV 0.31
100 ng/mL: Mean Rate 340.1, SD 1.07, % CV 0.32
Semi-quantitative:
Mean Recovery:
18 ng/mL: 17.1, SD 0.43, % CV 2.49
25 ng/mL: 24.3, SD 0.55, % CV 2.26
32 ng/mL: 31.4, SD 0.60, % CV 1.91
Sensitivity: 1 ng/mL
Accuracy: Vs. DRI's PCP EIA
Sensitivity: 100%
Specificity: 100%
Analytical Recovery:
Qualitative: 100 % accurate of positive vs. negative tests
Semi-quantitative: Quantitates within ±10% of the nominal concentration between 8 ng/mL and 80 ng/mL.
96.1% recovery at 18 ng/mL level (Cutoff - 25%)
97.8% recovery at 32 ng/mL level (Cutoff + 25%)
Specificity: Comparable to the predicate device.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAY 1 0 2002
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name. Address, and Contact
Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131 Phone: (408) 944-0360 (408) 944-0358 Fax:
Chiu Chin Chang, Ph.D. Contact: VP. R&D
Device Name and Classification
| Classification Name: | Phencyclidine test system, Class II, LCM (91 Toxicology) |
|---|---|
| Common Name: | Homogeneous enzyme immunoassay for the determination of |
| phencyclidine levels in urine. | |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.' Phencyclidine Enzyme Immunoassay is substantially equivalent to the Phencyclidine Enzyme Immunoassay by Diagnostic Reagents Inc. (now Microgenics, Inc.), cleared under premarket notification K935320.
LZI's Phencyclidine Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
LZI's Phencyclidine Enzyme Immunoassay is a ready-to-use, liguid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect phencyclidine in human urine with minimal cross-reactivity to various phencyclidine-related compounds and/or common drugs.
1
The assay is based on competition between phencyclidine labeled with enzyme glucose-6phosphate dehydrogenase (G6PDH), and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Phencyclidine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of phencyclidine (PCP) in human urine.
Comparison to Predicate Device
LZI's Phencyclidine Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed DRI Phencyclidine Enzyme Immunoassay (K935320),
The following table compares LZI's Phencyclidine Enzyme Immunoassay with the predicate device, DRI's Phencyclidine Enzyme Immunoassay. Specific data on the performance of the test have been incorporated into the proposed product insert (Attachment A). Product inserts for the predicate device and two other commercial products of similar intended use are provided in the Attachment C.
Similarities:
- Both assays are for qualitative and semi-quantitative determination of PCP in � human urine.
- Both assays use the same method principle, and device components. ●
- Both assay use 25 ng/mL as cutoff level per recommendations of The Substance . Abuse and Metal Health Services Administration (SAMHSA).
Differences:
Five (5) calibrators are available for semi-quantitative analysis. DRI's Phencyclidine Enzyme Immunoassay uses 3 calibrators previously. Two additional calibrators are also available commercially now.
2
(Comparison to Predicate Device, continued)
Performance Characteristics
.
:
: 上一篇: 上一篇:
:
100 M Fr
| Feature | DRI's
PCP EIA | | | | LZI's
Phencyclidine EIA | | | |
|-----------------------|--------------------------------------|--------------------------------------------|----|------|-------------------------------------------------|-------------------------------------|------|------|
| Within Run Precision: | | | | | | | | |
| Qualitative: | | Mean Rate | SD | % CV | | Mean Rate | SD | % CV |
| | Negative | 315 | - | 0.8 | Negative | 168.0 | 0.68 | 0.41 |
| | 20 ng/mL | 378 | - | 0.6 | 18 ng/mL | 238.6 | 1.16 | 0.49 |
| | 25 ng/mL | 400 | - | 0.5 | 25 ng/mL | 264.6 | 1.19 | 0.45 |
| | 35 ng/mL | 426 | - | 0.3 | 32 ng/mL | 282.8 | 1.42 | 0.50 |
| | 100 ng/mL | 502 | - | 0.4 | 100 ng/mL | 341.2 | 0.73 | 0.21 |
| Semi-quantitative: | No data available | | | | Mean Recovery | | | |
| | | | | | 18 ng/mL | 17.4 | 0.27 | 1.54 |
| | | | | | 25 ng/mL | 24.7 | 0.37 | 1.50 |
| | | | | | 32 ng/mL | 31.6 | 0.54 | 1.71 |
| Run-To-Run Precision: | | | | | | | | |
| Qualitative: | | Mean Rate | SD | % CV | | Mean Rate | SD | % CV |
| | Negative | 316 | - | 0.6 | Negative | 168.0 | 0.90 | 0.54 |
| | 20 ng/mL | 380 | - | 0.9 | 18 ng/mL | 238.8 | 0.55 | 0.23 |
| | 25 ng/mL | 400 | - | 0.6 | 25 ng/mL | 264.6 | 0.79 | 0.30 |
| | 35 ng/mL | 425 | - | 1.0 | 32 ng/mL | 284.1 | 0.87 | 0.31 |
| | 100 ng/mL | 501 | - | 0.9 | 100 ng/mL | 340.1 | 1.07 | 0.32 |
| Semi-quantitative: | No data available | | | | | Mean Recovery | | |
| | | | | | 18 ng/mL | 17.1 | 0.43 | 2.49 |
| | | | | | 25 ng/mL | 24.3 | 0.55 | 2.26 |
| | | | | | 32 ng/mL | 31.4 | 0.60 | 1.91 |
| Sensitivity: | 5 ng/mL | | | | 1 ng/mL | | | |
| Accuracy: | Vs. a commercially available EIA | | | | Vs. DRI's PCP EIA | | | |
| Sensitivity: | 100% | | | | 100% | | | |
| Specificity: | 100% | | | | 100% | | | |
| Analytical Recovery: | | | | | | | | |
| | Qualitative: No data available | | | | 100 % accurate of positive vs. negative tests | | | |
| | Semi-quantitative: No data available | | | | Quantitates within ±10% of the nominal | | | |
| | | | | | concentration between 8 ng/mL and 80 ng/mL. | | | |
| | | | | | 96.1% recovery at 18 ng/mL level (Cutoff - 25%) | | | |
| | | | | | 97.8% recovery at 32 ng/mL level (Cutoff + 25%) | | | |
| Specificity: | | See attached DRI PCP EIA package
insert | | | | Comparable to the predicate device. | | |
progr
:
:
،
3
Conclusion
LZI's Phencyclidine Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.
We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Phencyclidine Enzyme Immunoassay to other PCP test systems currently marketed in the United States.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 0 2002
Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131-1124
Re: K020254
Trade/Device Name: Phencyclidine Enzyme Immunoassay Regulatory Class: Class II Product Code: LCM Dated: April 15, 2002 Received: April 24, 2002
Dear Dr. Chang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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.
5
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This leater inn and it your ding of substantial equivalence of your device to a legally marketed noutication. This in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-42 contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on Judi resistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Premarket Notification
Indications for Use Statement
510 (K) Number (if known): _ KQ2003SY
Device Name: Phencyclidine Enzyme Immunoassay
Indications for Use:
The Phencyclidine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of phencyclidine (PCP) in human urine.
The Phencyclidine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method 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-ofabuse test result, particularly when preliminary positive results are used.
Jean Cooper
(Division Sign-Off)
vision of Clinical Laboratory Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)