(55 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Urine Phencyclidine (PCP) Screen Flex® reagent cartridge, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds. However, we can infer the performance metrics evaluated and their reported outcomes:
| Performance Metric | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (Agreement with Predicate) | High percentage agreement with the predicate device (Abbott AxSYM® System Phencyclidine II Assay) at the 25 ng/mL cutoff. | 98% agreement with the predicate method. |
| Qualitative Analysis (Agreement with GC/MS for Discordant Samples) | Discordant samples should have GC/MS values that explain the discrepancy. | 5 discordant samples (positive by PCP method, negative by AxSYM) had GC/MS values of 24, 20, 25, 19, 44 ng/mL. |
| Qualitative Spiked Sample Recovery (Negatives) | Samples spiked at <= 25% of the cutoff (0-18.75 ng/mL) should be consistently negative. | Consistently distinguished as negative. |
| Qualitative Spiked Sample Recovery (Positives) | Samples spiked at >= 25% of the cutoff (31.25-1000 ng/mL) should be consistently positive. | Consistently distinguished as positive. |
| Semiquantitative Spiked Sample Recovery | Quantitated values should be within 10% of the nominal concentration. | Quantitated within 10% of the nominal concentration between 8 and 75 ng/mL. |
| Semiquantitative Precision (Within-run %CV) | Acceptable within-run precision for controls and cutoff concentrations. Specific threshold not given, but industry standards for immunoassays typically aim for low CVs (e.g., <10%). | 2.1 to 5.0% for controls and cutoff concentrations. |
| Semiquantitative Precision (Total %CV) | Acceptable total precision for controls and cutoff concentrations. Specific threshold not given. | 5.5 to 6.5% for controls and cutoff concentrations. |
| Correlation with GC/MS (Semiquantitative) | Good relationship between semiquantitative readings and GC/MS values. | "The comparative analyses demonstrated a good relationship between the semiquantitative analyses and GC/MS values." (No specific correlation coefficient provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Qualitative Comparative Analysis (PCP vs. AxSYM): 213 specimens.
- GC/MS Confirmation (Diconcordant & Selected): 42 samples (all positive by PCP method and a portion of negative samples).
- Spiked Sample Recovery: Not explicitly stated, but performed at various known concentrations.
- Precision Study: Not explicitly stated, but performed at the 25 ng/mL cutoff level and controls at +/- 25% of the cutoff.
- Data Provenance: The document does not specify the country of origin. It appears to be retrospective, utilizing pre-collected specimens for the comparative analysis and GC/MS confirmation, and laboratory-prepared spiked samples for recovery and precision.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth was established by laboratory reference methods (GC/MS) or by the performance of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of expert review. Ground truth was established by a reference method (GC/MS) or comparison to a predicate device. For the comparative analysis, any discrepancies between the test device and the predicate were further investigated by GC/MS.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay, not an imaging-based or clinical decision support AI system where human reader performance would be directly evaluated. Its performance is assessed against analytical methods and predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this entire study represents a standalone performance evaluation. The "Urine Phencyclidine (PCP) Screen Flex® reagent cartridge" on the "Dimension® clinical chemistry system" operates as an automated assay. The results are generated by the device, and its performance is assessed analytically (precision, accuracy against known standards, agreement with predicate/GC/MS), without human interpretation as part of the primary diagnostic output.
7. The Type of Ground Truth Used
- For Qualitative Analysis (Comparative): The predicate device (Abbott AxSYM® System Phencyclidine II Assay) served as an initial "ground truth" for comparison, with Gas Chromatography/Mass Spectrometry (GC/MS) used as the definitive confirmatory ground truth for discordant samples and a portion of positive/negative samples.
- For Spiked Sample Recovery: Known concentrations of phencyclidine in spiked samples.
- For Precision: Known concentrations of controls and cutoff-level samples.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" because this device is a reagent cartridge for an enzyme immunoassay, not a machine learning or AI model that typically requires a distinct training phase. Its performance is intrinsically linked to the chemical reactions and optical detection system designed within the assay.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no explicitly defined "training set" in the context of this traditional immunoassay device. The assay's "design" or "calibration" (analogous to training in ML) would have been established through internal R&D processes using purified analytes and characterized matrices, but this is not detailed in the 510(k) summary.
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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 GroupRoute 896Newark, DE 19702 |
|---|---|
| Contact Information | Judy McInnis-Berger or Cathy P. CraftDade Behring Inc.GBC Bldg 500 Mailbox 514P.O. Box 6101Newark, 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.
:
N/A