(177 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML techniques. The performance studies focus on traditional analytical metrics like concordance and precision.
No.
The device is an in vitro diagnostic assay used for qualitative analysis of phencyclidine in human urine, which provides a preliminary analytical test result for diagnostic purposes. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of phencyclidine use or overdose."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, indicating it is a physical test kit or system, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the qualitative analysis of phencyclidine in human urine and that the measurements are used in the diagnosis and treatment of phencyclidine use or overdose. This clearly indicates a diagnostic purpose.
- Device Description: The "Device Description" section describes the assay as an "in vitro diagnostic assay for the qualitative analysis of Phencyclidine in human urine." This directly labels the device as an IVD.
- Sample Type: The device analyzes human urine, which is a biological specimen. IVDs are designed to test biological specimens.
- Clinical Laboratories: The intended user is clinical laboratories, which are settings where diagnostic testing is performed.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Phencyclidine assay is used for the qualitative analysis of phencyclidine in human urine with a cutoff of 25 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of phencyclidine use or overdose.
The Phencyclidine assay is calibrated with phencyclidine and will detect phencyclidine and its metabolites and analogs.
The Phencyclidine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical 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 used.
Product codes
LCM
Device Description
Phencyclidine is an in vitro diagnostic assay for the qualitative analysis of Phencyclidine in human urine. The assay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
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
clinical laboratories
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
Not Found
Summary of Performance Studies
Comparative performance studies were conducted using the AEROSET® System. The Phencyclidine assay method comparison yielded acceptable correlation with the Emit II Phencyclidine assuy on the SYVA-30R Analyzer. The concordance table for the AEROSET Phencyclidine assay shows 99% agreement. One sample was positive using the Phencyclidine assay and negative using the Emit II Phencyclidine assay on the SYVA-30R Analyzer. This sample was shown to contain 14.9 ng/mL of phencyclidine as determined by GCMS. The Phencyclidine assay method comparison yielded acceptable correlation with GC/MS. The concordance table for the AEROSET Phencyclidine assay shows 93% agreement with GC/MS. The clinical specimens tested ranged from 14.9 to 78.5 ng/mL. Precision studies were conducted using the Phencyclidine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 1.42%. The total %CV for the Cutoff Calibrator is 2.14%. The total %CV for Verifier II is 1.03%. The total %CV for the - 25% and the + 25% Control of Cutoff Calibrator samples are 2.20% and 2.07%, respectively.
Key Metrics
The concordance table for the AEROSET Phencyclidine assay shows 99% agreement. The concordance table for the AEROSET Phencyclidine assay shows 93% agreement with GC/MS. The total %CV for Verifier I is 1.42%. The total %CV for the Cutoff Calibrator is 2.14%. The total %CV for Verifier II is 1.03%. The total %CV for the - 25% and the + 25% Control of Cutoff Calibrator samples are 2.20% and 2.07%, respectively. The Phencyclidine assay cutoff is 25 ng/mL. The limit of detection (sensitivity) of the Phencyclidine assay is 3 ng/mL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAR 1 3 2002
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 1-8 Irving, Texas 75038
Contact Person Linda Morris Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
November 21, 2001 Date of Preparation of this Summary: Device Trade or Proprietary Name: Phencyclidine Device Common/Usual Name or Classification Name: Phencyclidine LCM/Class II Classification Number/Class:
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.
The assigned 510(k) number is: K013096.
Test Description:
Phencyclidine is an in vitro diagnostic assay for the qualitative analysis of Phencyclidine in human urine. The assay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
1
Substantial Equivalence:
The Phencyclidine assay is substantially equivalent to the Emil® II Phencyclidine assay (K904765) on the SYVA®-30R Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoassays. .
- Both assays can be used for the qualitative analysis of Phencyclidine. .
- Both assays vield similar results. .
- Both assays are based on the competition between drug in the specimen and drug labeled with the . enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
- Both assays have the same assay ranges (cutoff). t
Differences:
- The Phencyclidine assay is qualitative. The Emit II Phencyclidine assay is qualitative and . semiquantitative.
Intended Use:
The Phencyclidine assay is used for the qualitative analysis of phencyclidine in human urine with a cutoff of 25 ng/mL. For use in clinical laboratories.
The Phencyclidine assay is calibrated with phencyclidine and will detect phencyclidine and its metabolites and analogs.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Phencyclidine assay method comparison yielded acceptable correlation with the Emit II Phencyclidine assuy on the SYVA-30R Analyzer. The concordance table for the AEROSET Phencyclidine assay shows 99% agreement. One sample was positive using the Phencyclidine assay and negative using the Emit II Phencyclidine assay on the SYVA-30R Analyzer. This sample was shown to contain 14.9 ng/mL of phencyclidine as determined by GCMS. The Phencyclidine assay method comparison yielded
2
acceptable correlation with GC/MS. The concordance table for the AEROSET Phencyclidine assay shows 93% agreement with GC/MS. The clinical specimens tested ranged from 14.9 to 78.5 ng/mL. Precision studies were conducted using the Phencyclidine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 1.42%. The total %CV for the Cutoff Calibrator is 2.14%. The total %CV for Verifier II is 1.03%. The total %CV for the - 25% and the + 25% Control of Cutoff Calibrator samples are 2.20% and 2.07%, respectively. The Phencyclidine assay cutoff is 25 ng/mL. The limit of detection (sensitivity) of the Phencyclidine assay is 3 ng/mL. These data demonstrate that the performance of the Phencyclidine assay is substantially equivalent to the performance of the Emit II Phencyclidine assay on the SYVA-30R Analyzer.
Conclusion:
The Phencyclidine assay is substantially equivalent to the Emit® II Phencyclidine assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 2002
Ms. Linda Morris Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038
Re: K013096 Trade/Device Name: Phencyclidine Regulatory Class: Class II Product Code: LCM Dated: November 26, 2001 Received: November 28, 2001
Dear Ms. Morris:
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.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in your your substantial equivalence of your device to a legally marketed predicate device results 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 ' If you desire bpoint an invitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-15681 - 12 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 mornation on your house and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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
5
510(k) Number (if known): K013096
Phencyclidinc Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Phencyclidine assay is used for the qualitative analysis of phencyclidine in human urine with a cutoff of 25 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of phencyclidine use or overdose.
The Phencyclidine assay is calibrated with phencyclidine and will detect phencyclidine and its metabolites and analogs.
The Phencyclidine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical 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 used.
(Division Sign-Off)
Division of C
510(k) Number crato
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NE'DEE
| 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) |