(55 days)
Abbott AxSYM® System Phencyclidine II Assay
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No
The summary describes a standard in vitro diagnostic immunoassay with performance metrics based on comparative analysis, spiked samples, and precision, with no mention of AI or ML.
No.
This device is an in vitro diagnostic test used for determining the presence of phencyclidine in human urine, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose."
No
The device description clearly states it is a "reagent cartridge" and a "homogenous enzyme assay," which are physical components used in a laboratory setting, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says the device "provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phencyclidine in human urine." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description further clarifies that it's a "homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of phencyclidine in human urine." This describes a laboratory test performed on a biological sample (urine) outside of the body.
- Performance Studies: The performance studies described (Comparative Analysis, Spiked Sample Recovery, Precision) are typical evaluations performed on IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device(s)" (Abbott AxSYM® System Phencyclidine II Assay) is common in regulatory submissions for IVD devices, where a new device is compared to a previously cleared device.
All these elements strongly indicate that the PCP Flex® reagent cartridge is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PCP Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
Product codes (comma separated list FDA assigned to the subject device)
LCM
Device Description
The Urine Phencyclidine (PCP) Screen Flex® reagent cartridge is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of phencyclidine in human urine. The PCP method has been found to be substantially equivalent to the predicate device, Abbott AxSYM® System Phencyclidine II Assay, with regard to intended use, assay sample, and overall performance characteristics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis
The Dimension® method showed excellent correlation to the Abbott AxSYM® System Phencyclidine II Assay (comparative method) in qualitative analysis. 213 specimens were tested. 42 samples were positive and 166 amples were negative by both methods. The percent agreement between the PCP method and the comparative method using the 25 ng/mL cutoff result was 98%. Five (5) discordant sample was positive by the PCP method and negative by the AxSYM® method. The GC/MS values are listed below:
Discrepant specimens (ng/mL):
(Phencyclidine)
24
20
25
19
44
All positive samples and a portion of negative samples (n=42), as assessed by the PCP method, were analyzed by GC/MS for confirmatory purposes. The comparative analyses demonstrated a good relationship between the semiquantitative analyses and GC/MS values.
Spiked Sample Recovery
The qualitative and semiquantitative attributes were assessed by determining the accuracy of recovery for the analyte in spiked samples PCP method.
For the qualitative method, known levels of phencyclidine, spiked at levels less than or equal to minus 25% of the 25 ng/mL cutoff (0 - 18.75) and spiked levels greater than or equal to plus 25% of the 25ng/mL cutoff (31.25 - 1000 ng/mL) were consistently distinquished as negative or positive.
The semiquantitative results for known spiked concentrations for the Urine Phencyclidine (PCP) Screen Flex® reagent cartridge quantitated within 10% of the nominal concentration between 8 and 75 ng/mL.
Precision
A precision study was performed on the 25 ng/mL cutoff level and controls at +/- 25% of the cutoff using the Dimension® PCP method in the semiquantitative mode. Acceptable within run and total precision statistics in the semiquantitative assay were observed.
In the semiquantitative mode the with-in run precision demonstrated coefficients of variation (%CV) for controls and cutoff concentrations ranging from 2.1 to 5.0% and for total precision %CV ranging from 5.5 to 6.5%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent agreement: 98%
Qualitative method: Known levels spiked at = 25% of 25ng/mL cutoff (31.25-1000 ng/mL) were consistently distinguished as negative or positive.
Semiquantitative results: Quantitated within 10% of nominal concentration between 8 and 75 ng/mL.
Precision: Within-run precision (%CV) for controls and cutoff concentrations ranging from 2.1 to 5.0%. Total precision (%CV) ranging from 5.5 to 6.5%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Abbott AxSYM® System Phencyclidine II Assay
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2017
Dade Behring Inc. Ms. Judy McInnis-Berger Senior Regulatory Specialist Route 896, Glasgow Business Center P.O. Box 6101 Newark, Delaware 19714
Re: K000462
Trade/Device Name: Urine Phencyclidine (PCP) Screen Flex reagent cartridge Regulation Number: Unclassified Regulation Name: Enzyme Immunoassay, Phencyclidine Regulatory Class: Unclassified, 510(k) required Product Code: LCM Dated: February 9, 2000 Received: February 11, 2000
Dear Ms. McInnis-Berger:
This letter corrects our substantially equivalent letter of April 6, 2000.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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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Device Name: Urine Phencyclidine (PCP) Screen Flex® reagent cartridge
Indications for Use:
The PCP Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number Kca462
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
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DADE BEHRING
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Manufacturer and Contact Information:
| Manufacturer - Final Product | Dade Behring Inc.
Chemistry Group
Route 896
Newark, DE 19702 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Judy McInnis-Berger or Cathy P. Craft
Dade Behring Inc.
GBC Bldg 500 Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101 |
| Manufacturer - Bulk Product | Syva Company - Dade Behring Inc.
20400 Mariani Ave.
Cupertino, CA 95014 |
2. Device Classification Name:
"Phencyclidine test system" has been classified as Class II by the Clinical Chemistry and Clinical Toxicology Devices Panel. Reference: Federal Register, Volume 52, Number 84, May 1987
3. Intended Use:
The PCP Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semiquantative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
4. Device Description and Characteristics:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
The Urine Phencyclidine (PCP) Screen Flex® reagent cartridge is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of phencyclidine in human urine. The PCP method has been found to be substantially equivalent to the predicate device, Abbott AxSYM® System Phencyclidine II Assay, with regard to intended use, assay sample, and overall performance characteristics.
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Comparative Analysis
The Dimension® method showed excellent correlation to the Abbott AxSYM® System Phencyclidine II Assay (comparative method) in qualitative analysis. 213 specimens were tested. 42 samples were positive and 166 amples were negative by both methods. The percent agreement between the PCP method and the comparative method using the 25 ng/mL cutoff result was 98%. Five (5) discordant sample was positive by the PCP method and negative by the AxSYM® method. The GC/MS values are listed below:
Discrepant specimens (ng/mL):
| GC/MS | (Phencyclidine) |
|---|---|
| 24 | |
| 20 | |
| 25 | |
| 19 | |
| 44 |
All positive samples and a portion of negative samples (n=42), as assessed by the PCP method, were analyzed by GC/MS for confirmatory purposes. The comparative analyses demonstrated a good relationship between the semiquantitative analyses and GC/MS values.
Spiked Sample Recovery
The qualitative and semiquantitative attributes were assessed by determining the accuracy of recovery for the analyte in spiked samples PCP method.
For the qualitative method, known levels of phencyclidine, spiked at levels less than or equal to minus 25% of the 25 ng/mL cutoff (0 - 18.75) and spiked levels greater than or equal to plus 25% of the 25ng/mL cutoff (31.25 - 1000 ng/mL) were consistently distinquished as negative or positive.
The semiquantitative results for known spiked concentrations for the Urine Phencyclidine (PCP) Screen Flex® reagent cartridge quantitated within 10% of the nominal concentration between 8 and 75 ng/mL.
Precision
A precision study was performed on the 25 ng/mL cutoff level and controls at +/- 25% of the cutoff using the Dimension® PCP method in the semiquantitative mode. Acceptable within run and total precision statistics in the semiquantitative assay were observed.
In the semiquantitative mode the with-in run precision demonstrated coefficients of variation (%CV) for controls and cutoff concentrations ranging from 2.1 to 5.0% and for total precision %CV ranging from 5.5 to 6.5%.
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5. Substantial Equivalence:
In conclusion, Dade Behring Inc. considers the Urine Phencyclidine (PCP) Screen Flex® reagent cartridge to be substantially equivalent to the Abbott AxSYM® System Phencyclidine II Assay with regard to intended use, assay sample, and overall performance characteristics.
: