(210 days)
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No
The summary describes a standard immunoassay for measuring procalcitonin levels and does not mention any AI or ML components. The performance studies focus on analytical performance metrics typical of laboratory assays.
No
This device is an in vitro diagnostic assay used for measuring PCT levels to aid in risk assessment for severe sepsis and septic shock, not for treatment.
Yes
The device quantitatively measures procalcitonin levels, which, "in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients ... for progression to severe sepsis and septic shock." This process of aiding in risk assessment for a medical condition is a diagnostic function.
No
The device description explicitly details the components of a reagent pack, which are physical substances used in a laboratory assay. This indicates the device includes hardware (reagents) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma". This indicates the device is used to test samples taken from the human body outside of the body.
- Device Description: The description details the components of the "reagent pack" used in the assay, which are substances used to perform the in vitro test.
- Performance Studies: The document describes various performance studies (Method Comparison, Imprecision, Linearity, Limit of Blank, Limit of Detection, Limit of Quantitation) which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K192271; Access PCT Assay) strongly suggests that this device is being compared to a previously cleared IVD device, a common practice in regulatory submissions for IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
Product codes (comma separated list FDA assigned to the subject device)
PTF
Device Description
The Access PCT assay is a paramaqnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.A description of the reagent pack is provided below.
- R1a: Dynabeads* paramagnetic particles coated with mouse anti-. human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
- R1b: 0.10 N Sodium Hydroxide ●
- R1c: MOPS Buffer with surfactant and protein (bovine, murine), ≤ ● 0.1 % sodium azide, and 0.1% ProClin 300
- R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase . coniugate in a MOPS buffer with surfactant and protein (bovine, murine, recombinant).
≤ 0.1% sodium azide, and 0.1% ProClin 300
*Dynabead® is a registered trademark of Dynal A.S., Oslo, Norway **ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliate company of Dow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
critically ill patients on their first day of Intensive Care Unit (ICU) admission
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: The results of the method comparison study met the acceptance criteria of R2 ≥ 0.95 and slope 1.00 ± 0.10 and supports the equivalence of the Access PCT assay on Dxl 9000 to the Access PCT assay on Access 2 Instrument. The bias data supports the reference intervals defined on the Access 2 system have not changed appreciably on the Dxl 9000 system.
Method Concordance: The percentage of concordance between the Access 2 lmmunoassay System and the Dxl 9000 Access Immunoassay Analyzer for the cut-offs of 0.5 and 2.0 ng/mL were 100.0% and 98.3%, respectively.
lmprecision: The Within Laboratory (total) % CV was between 2.2% and 6.1% for PCT concentrations ≥ 0.150 ng/mL. The Within laboratory (total) SD was between 0.006 - 0.008 for PCT concentrations 0.150 ng/mL.
Limit of Blank (LoB): The data demonstrated the LoB estimate of the PCT assay is 0.002 ng/mL. which met the acceptance criteria of ≤ 0.005 ng/mL.
Limit of Detection (LoD): The data demonstrated the LoD estimate of PCT is 0.003 ng/mL which met the acceptance criteria of ≤ 0.01 ng/mL.
Limit of Quantitation (LoQ): The results demonstrated the 20% CV LoQ estimate for the Access PCT assay to be 0.002 ng/mL which meets the acceptance criteria of less than or equal to 0.02 ng/mL.
The maximum observed LoQ estimate for Access PCT assay on the Dxl 9000 immunoassay System is less than the reported LoD value (0.003ng/mL). Following the CLSI EP17-A2 recommendation that the LoQ must be greater than or equal to LoD, the LoQ value is reported as 0.003 ng/mL to align with LoD.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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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
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.
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April 26, 2023
Beckman Coulter, Inc Neha Desai Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K222996
Trade/Device Name: Access PCT Regulation Number: 21 CFR 866.3215 Regulation Name: Device To Detect And Measure Non-Microbial Analyte(s) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis Regulatory Class: Class II Product Code: PTF Dated: September 27, 2022 Received: September 28, 2022
Dear Neha Desai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Noel J. Gerald -S
Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222996
Device Name Access PCT
Indications for Use (Describe)
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Access PCT 510(K) Summary
Immunodiagnostic Development Center
1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).
The assigned 510(k) number is K222996
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 368-7610
Contact Person:
Neha Desai 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (612) 244-9788 Email: nhdesai@beckman.com
Alternate Contact:
Kulieet Kaur Office Phone: (952) 465-1914 Email: kkaur@beckman.com
Date Prepared:
February 17th, 2023
Device Name:
Proprietary / Trade Name: Access PCT Reagent Common Name: Procalcitonin Immunoassay Classification Name: Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis Classification Regulation: 21 CFR 866.3215 Classification Product Code: PTF
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Predicate Device:
The Access PCT Assay/Calibrators claims substantial equivalence to previously cleared Access PCT Assay FDA 510(k) Number K192271.
Device Description:
The Access PCT assay is a paramaqnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe
sepsis and septic shock.A description of the reagent pack is provided below.
- R1a: Dynabeads* paramagnetic particles coated with mouse anti-. human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
- R1b: 0.10 N Sodium Hydroxide ●
- R1c: MOPS Buffer with surfactant and protein (bovine, murine), ≤ ● 0.1 % sodium azide, and 0.1% ProClin 300
- R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase . coniugate in a MOPS buffer with surfactant and protein (bovine, murine, recombinant).
≤ 0.1% sodium azide, and 0.1% ProClin 300
*Dynabead® is a registered trademark of Dynal A.S., Oslo, Norway **ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliate company of Dow.
Intended Use:
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
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Comparison of Technological Characteristics to the Predicate (Assay)
| Predicate Access PCT on | Access PCT on Dxl 9000 | |
|---|---|---|
| System | Access 2 Immunoassay | Access Immunoassay |
| Attribute/Characteristic | System (K192271) | Analyzer |
| Intended Use/ | ||
| Indications for Use | The Access PCT assay is a | |
| paramagnetic particle, | ||
| chemiluminescent | ||
| immunoassay for in vitro | ||
| quantitative determination of | ||
| procalcitonin (PCT) levels in | ||
| human serum and plasma | ||
| (lithium heparin and EDTA) | ||
| using the Access | ||
| Immunoassay System. | ||
| Measurement of PCT in | ||
| conjunction with other | ||
| laboratory findings and clinical | ||
| assessment aids in the risk | ||
| assessment of critically ill | ||
| patients on their first day of | ||
| Intensive Care Unit (ICU) | ||
| admission for progression to | ||
| severe sepsis and septic | ||
| shock. | Same | |
| Analyte Measured | Procalcitonin (PCT) | Same |
| Technology | Two-step sandwich | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration | |
| curve | Same | |
| Sample Type | Human Serum or Plasma | |
| (LiHep and EDTA) | Same | |
| Measuring Range | 0.05 to 100 ng/mL | Same |
| LoB | ≤ 0.005 ng/mL | Same |
| LoD | ≤ 0.01 ng/mL | Same |
| LoQ | 20% CV at ≤ 0.02 ng/mL | Same |
| Hook | No hook effect up to | |
| procalcitonin concentrations of | ||
| 5,000 ng/mL | Same | |
| Stability | Stable at 2 to 10°C for 42 days | |
| after initial use | Same | |
| Reagent Pack materials | Mouse anti-human | |
| procalcitonin monoclonal | ||
| antibody | Same | |
| Assay Duration | Approximately 20 minutes | Approximately 14 minutes |
| System | ||
| Attribute/Characteristic | Predicate Access PCT on | |
| Access 2 Immunoassay | ||
| System (K192271) | Access PCT on Dxl 9000 | |
| Access Immunoassay | ||
| Analyzer | ||
| Sample Volume | 35 µL | 15 µL |
| Instrument | Access 2 Immunoassay | |
| system | Dxl 9000 Access | |
| Immunoassay Analyzer | ||
| Substrate | Access Substrate | Lumi-Phos PRO substrate |
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Summary of Studies
Method Comparison: The results of the method comparison study met the acceptance criteria of R2 ≥ 0.95 and slope 1.00 ± 0.10 and supports the equivalence of the Access PCT assay on Dxl 9000 to the Access PCT assay on Access 2 Instrument. The bias data supports the reference intervals defined on the Access 2 system have not changed appreciably on the Dxl 9000 system.
Method Concordance: The percentage of concordance between the Access 2 lmmunoassay System and the Dxl 9000 Access Immunoassay Analyzer for the cut-offs of 0.5 and 2.0 ng/mL were 100.0% and 98.3%, respectively.
lmprecision: The Within Laboratory (total) % CV was between 2.2% and 6.1% for PCT concentrations ≥ 0.150 ng/mL. The Within laboratory (total) SD was between 0.006 - 0.008 for PCT concentrations 0.150 ng/mL.
Limit of Blank (LoB): The data demonstrated the LoB estimate of the PCT assay is 0.002 ng/mL. which met the acceptance criteria of ≤ 0.005 ng/mL.
Limit of Detection (LoD): The data demonstrated the LoD estimate of PCT is 0.003 ng/mL which met the acceptance criteria of ≤ 0.01 ng/mL.
Limit of Quantitation (LoQ): The results demonstrated the 20% CV LoQ estimate for the Access PCT assay to be 0.002 ng/mL which meets the acceptance criteria of less than or equal to 0.02 ng/mL
The maximum observed LoQ estimate for Access PCT assay on the Dxl 9000 immunoassay System is less than the reported LoD value (0.003ng/mL). Following the CLSI EP17-A2 recommendation that the LoQ must be greater than or equal to LoD, the LoQ value is reported as 0.003 ng/mL to align with LoD.
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Conclusion:
The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the PCT assay on Dxl 9000 Access Immunoassay Analyzer.