(172 days)
Not Found
No
The summary describes a standard immunoassay for measuring hormone levels and does not mention any AI or ML components in the device description or performance studies.
No
This device is an in vitro diagnostic assay used for the quantitative determination of parathyroid hormone levels, indicated to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy."
No
The device description explicitly states it consists of a reagent pack and calibrators, which are physical components, not software. It also mentions use with an Immunoassay Analyzer, which is a hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: It describes a "paramagnetic particle, chemiluminescent immunoassay" and components like "reagent pack and calibrators", "substrate and wash buffers". These are all typical components of an in vitro diagnostic test.
- Care Setting: It is designed for use "on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting". Clinical laboratories are where in vitro diagnostic testing is performed.
- Performance Studies: The performance studies described (Imprecision, Linearity, LoB, LoD, LoQ, Method Comparison) are standard types of studies conducted to validate the performance of in vitro diagnostic assays.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K061190) and the name "Access Intact PTH" strongly indicates that this device is being compared to a previously cleared IVD.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
The Access Intact PTH assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The Access intact PTH assay reagent pack, Access intact PTH assay calibrators, along with the Access wash buffer and substrate are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Imprecision:
- Study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer.
- Multiple samples tested in duplicate in 2 runs per day for a minimum of 20 days.
- Routine Mode assay and Intraoperative Mode assay were designed to have within-laboratory imprecision:
- ≤ 0.96 pg/mL (0.10 pmol/L) SD at concentrations ≤ 12 pg/mL (1.3 pmol/L).
- ≤ 8.0% CV at concentrations > 12 pg/mL (1.3 pmol/L).
Linearity:
- Study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer.
- The assay demonstrated linearity across the measuring interval.
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ):
- Studies conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2.
- LoB study included multiple reagent lots and 3 instruments over a minimum of 3 days.
- LoD and LoQ studies included multiple reagent lots and 3 instruments over a minimum of 5 days.
Method Comparison:
- Study based on CLSI EP09c, 3rd Edition using Weighted Deming regression and Pearson's correlation.
- Compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
- ROUTINE MODE: N=144, Concentration Range* (pg/mL) 2.2 - 3278, Slope=0.97, Slope 95% CI=0.96 - 0.98, Intercept=-0.23, Intercept 95% CI=-0.33 - (-0.12), Correlation Coefficient R=1.00.
- ROUTINE MODE: N=144, Concentration Range* (pmol/L) 0.23 - 347, Slope=0.97, Slope 95% CI=0.96 - 0.98, Intercept=-0.024, Intercept 95% CI=-0.035 - (-0.013), Correlation Coefficient R=1.00.
- INTRAOPERATIVE MODE: N=116, Concentration Range* (pg/mL) 2.3 - 3677, Slope=1.02, Slope 95% CI=1.00 - 1.04, Intercept=-0.081, Intercept 95% CI=-0.36 - 0.20, Correlation Coefficient R=0.99.
- INTRAOPERATIVE MODE: N=116, Concentration Range* (pmol/L) 0.24 - 390, Slope=1.02, Slope 95% CI=1.00 - 1.04, Intercept=-0.0086, Intercept 95% CI=-0.038 - 0.021, Correlation Coefficient R=0.99.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Imprecision (Within-Laboratory)
Routine Mode:
- Sample 1: 7.8 pg/mL (0.83 pmol/L), SD=0.46 pg/mL (0.05 pmol/L), %CV=5.9%
- Sample 2: 12 pg/mL (1.3 pmol/L), SD=0.79 pg/mL (0.08 pmol/L), %CV=6.5%
- Sample 3: 89 pg/mL (9.4 pmol/L), SD=3.8 pg/mL (0.40 pmol/L), %CV=4.3%
- Sample 4: 1369 pg/mL (145 pmol/L), SD=50.3 pg/mL (5.3 pmol/L), %CV=3.7%
- Sample 5: 2449 pg/mL (260 pmol/L), SD=65.2 pg/mL (6.9 pmol/L), %CV=2.7%
IntraOperative Mode:
- Sample 1: 1.7 pg/mL (0.18 pmol/L), SD=0.23 pg/mL (0.02 pmol/L), %CV=13.2%
- Sample 2: 6.6 pg/mL (0.70 pmol/L), SD=0.33 pg/mL (0.03 pmol/L), %CV=5.0%
- Sample 3: 14 pg/mL (1.5 pmol/L), SD=0.7 pg/mL (0.07 pmol/L), %CV=4.8%
- Sample 4: 34 pg/mL (3.6 pmol/L), SD=1.4 pg/mL (0.15 pmol/L), %CV=4.2%
- Sample 5: 169 pg/mL (18 pmol/L), SD=6.8 pg/mL (0.7 pmol/L), %CV=4.0%
- Sample 6: 1014 pg/mL (107 pmol/L), SD=43.8 pg/mL (4.6 pmol/L), %CV=4.3%
- Sample 7: 2542 pg/mL (269 pmol/L), SD=83.5 pg/mL (8.9 pmol/L), %CV=3.3%
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)
ROUTINE MODE:
- Limit of Blank (LoB): 0.5 pg/mL (0.05 pmol/L)
- Limit of Detection (LoD): 0.7 pg/mL (0.08 pmol/L)
- Limit of Quantitation (LoQ) ≤ 20% within-lab CV: 0.7 pg/mL (0.08 pmol/L)
INTRAOPERATIVE MODE:
- Limit of Blank (LoB): 0.5 pg/mL (0.05 pmol/L)
- Limit of Detection (LoD): 0.8 pg/mL (0.08 pmol/L)
- Limit of Quantitation (LoQ) ≤ 20% within-lab CV: 0.8 pg/mL (0.08 pmol/L)
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.
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
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2024
Beckman Coulter, Inc. Neha Desai Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K232791
Trade/Device Name: Access Intact PTH Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: January 22, 2024 Received: January 22, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director
Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
K232791 Device Name
Access Intact PTH
Indications for Use (Describe)
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
lt is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
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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3
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.
510(k) Number K232791
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primarv Contact:
Neha Desai, Staff Quality and Regulatory Affairs Email: nhdesai@beckman.com Phone: (612) 244-9788
Alternate Contact:
Kuljeet Kaur, Regulatory Affairs Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914
Trade Name: Access Intact PTH Common Name: Parathvroid Hormone Test Classification Requlation: 21 CFR 862.1545 Classification Product Code: CEW
Predicate Device:
Access Intact PTH 510(k) Number K061190
Device Description
The Access Intact PTH assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The Access intact PTH assay reagent pack, Access intact PTH assay calibrators, along with the Access wash buffer and substrate are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.
Intended Use
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
4
| Comparison of Technological Characteristics to the Predicate (Assay) | ||
|---|---|---|
| System | ||
| Attribute/Characteristic | Predicate Access Intact PTH | |
| on Access 2 Immunoassay | ||
| System | Access Intact PTH on Dxl | |
| 9000 Access Immunoassay | ||
| Analyzer | ||
| Intended Use/ | ||
| Indications for Use | The Access Intact PTH assay | |
| is a paramagnetic particle, | ||
| chemiluminescent | ||
| immunoassay for the | ||
| quantitative determination of | ||
| intact parathyroid hormone | ||
| (parathyrin, PTH) levels in | ||
| human serum and plasma | ||
| using the Access | ||
| Immunoassay Systems. It is | ||
| indicated to aid in the | ||
| differential diagnosis of | ||
| hyperparathyroidism, | ||
| hypoparathyroidism, or | ||
| hypercalcemia of malignancy | ||
| and can be used | ||
| intraoperatively. Assay results | ||
| should be used in conjunction | ||
| with other clinical data to | ||
| assist the clinician in making | ||
| individual patient management decisions. | Same | |
| Assay Principle | The Access Intact PTH assay | |
| is a two-site immunoenzymatic | ||
| ( "sandwich" ) assay. A | ||
| sample is added to a reaction | ||
| vessel, along with a | ||
| monoclonal anti-PTH antibody | ||
| conjugated to alkaline | ||
| phosphatase, TRIS buffered | ||
| saline with proteins and | ||
| paramagnetic particles coated | ||
| with a goat polyclonal anti- | ||
| PTH antibody. | Same | |
| Solid Support | Paramagnetic Particles | Same |
| Calibration | Six levels (10, 60, 300, 1,500 | |
| and 3,500 pg/mL) of synthetic | ||
| PTH antigen in a buffered | ||
| protein solution with | ||
| preservatives | Same | |
| Sample Type | Serum or Plasma (Heparin | |
| and EDTA) | Same | |
| Measuring Range | 1 - 3,500 pg/mL | 1.7 - 3,500 pg/mL |
| Stability | Stable at 2 to 10°C for 28 days | Same |
| System | ||
| Attribute/Characteristic | Predicate Access Intact PTH | |
| on Access 2 Immunoassay | ||
| System | Access Intact PTH on Dxl | |
| 9000 Access Immunoassay | ||
| Analyzer | ||
| Instrument | Access 2 Immunoassay | |
| system | Dxl 9000 Access | |
| Immunoassay Analyzer | ||
| Substrate | Access Substrate | Lumi-Phos PRO substrate |
5
Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition
CLSI EP06-2nd Edition -: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples- Third Edition
Summary of Studies:
Imprecision:
The Routine Mode assay and Intraoperative Mode assay were designed to have withinlaboratory imprecision as listed below:
- ≤ 0.96 pg/mL (0.10 pmol/L) SD at concentrations ≤ 12 pg/mL (1.3 pmol/L) .
- ≤ 8.0% CV at concentrations > 12 pg/mL (1.3 pmol/L) ●
A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
6
Routine Mode:
| | Concentration (pg/mL) | | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | |
|----------|-----------------------|------|------|-------------------------------|------|-------------|------|-------------|------|-------------------|--|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Sample 1 | 86 | 7.8 | 0.19 | 2.4 | 0.10 | 1.2 | 0.41 | 5.2 | 0.46 | 5.9 | |
| Sample 2 | 86 | 12 | 0.48 | 3.9 | 0.40 | 3.3 | 0.48 | 4.0 | 0.79 | 6.5 | |
| Sample 3 | 86 | 89 | 2.1 | 2.3 | 2.1 | 2.3 | 2.4 | 2.7 | 3.8 | 4.3 | |
| Sample 4 | 86 | 1369 | 44.2 | 3.2 | 15.4 | 1.1 | 18.3 | 1.3 | 50.3 | 3.7 | |
| Sample 5 | 84 | 2449 | 48.9 | 2.0 | 14.2 | 0.6 | 40.8 | 1.7 | 65.2 | 2.7 | |
| | Concentration (pmol/L) | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | |
|----------|------------------------|------|-------------------------------|-----|-------------|-----|-------------|-----|-------------------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 86 | 0.83 | 0.02 | 2.4 | 0.01 | 1.2 | 0.04 | 5.2 | 0.05 | 5.9 |
| Sample 2 | 86 | 1.3 | 0.05 | 3.9 | 0.04 | 3.3 | 0.05 | 4.0 | 0.08 | 6.5 |
| Sample 3 | 86 | 9.4 | 0.22 | 2.3 | 0.22 | 2.3 | 0.25 | 2.7 | 0.40 | 4.3 |
| Sample 4 | 86 | 145 | 4.7 | 3.2 | 1.6 | 1.1 | 1.9 | 1.3 | 5.3 | 3.7 |
| Sample 5 | 84 | 260 | 5.2 | 2.0 | 1.5 | 0.6 | 4.3 | 1.7 | 6.9 | 2.7 |
IntraOperative Mode:
| IntraOperative Mode: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Concentration (pg/mL) | Repeatability | |||||||||
| (Within-Run) | Between-Run | Between-Day | Within-Laboratory | |||||||
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 88 | 1.7 | 0.15 | 8.6 | 0.13 | 7.3 | 0.12 | 6.9 | 0.23 | 13.2 |
| Sample 2 | 88 | 6.6 | 0.27 | 4.1 | 0.03 | 0.4 | 0.19 | 2.9 | 0.33 | 5.0 |
| Sample 3 | 88 | 14 | 0.6 | 4.0 | 0.0 | 0.0 | 0.4 | 2.7 | 0.7 | 4.8 |
| Sample 4 | 88 | 34 | 1.3 | 4.0 | 0.0 | 0.0 | 0.5 | 1.4 | 1.4 | 4.2 |
| Sample 5 | 88 | 169 | 5.5 | 3.3 | 3.1 | 1.8 | 2.4 | 1.4 | 6.8 | 4.0 |
| Sample 6 | 88 | 1014 | 41.7 | 4.1 | 0.0 | 0.0 | 13.1 | 1.3 | 43.8 | 4.3 |
| Sample 7 | 88 | 2542 | 72.3 | 2.8 | 41.7 | 1.6 | 0.0 | 0.0 | 83.5 | 3.3 |
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| Concentration (pmol/L) | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | |
|------------------------|----|-------------------------------|------|-------------|-----------|-------------|------|-------------------|------|------|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 88 | 0.18 | 0.02 | 8.6 | 0.01 | 7.3 | 0.01 | 6.9 | 0.02 | 13.2 |
| Sample 2 | 88 | 0.70 | 0.03 | 4.1 | 0.00
3 | 0.4 | 0.02 | 2.9 | 0.03 | 5.0 |
| Sample 3 | 88 | 1.5 | 0.06 | 4.0 | 0.0 | 0.0 | 0.04 | 2.7 | 0.07 | 4.8 |
| Sample 4 | 88 | 3.6 | 0.14 | 4.0 | 0.0 | 0.0 | 0.05 | 1.4 | 0.15 | 4.2 |
| Sample 5 | 88 | 18 | 0.6 | 3.3 | 0.3 | 1.8 | 0.3 | 1.4 | 0.7 | 4.0 |
| Sample 6 | 88 | 107 | 4.4 | 4.1 | 0.0 | 0.0 | 1.4 | 1.3 | 4.6 | 4.3 |
| Sample 7 | 88 | 269 | 7.7 | 2.8 | 4.4 | 1.6 | 0.0 | 0.0 | 8.9 | 3.3 |
Linearity:
A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ):
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2. The LoB study included multiple reagent lots and 3 instruments over a minimum of 3 days. The LoD and LoQ studies included multiple reagent lots and 3 instruments over a minimum of 5 days.
| Maximum Observed Result | Design Criteria | |||
|---|---|---|---|---|
| ROUTINE MODE | pg/mL | pmol/L | pg/mL | pmol/L |
| Limit of Blank | ||||
| (LoB) | 0.5 | 0.05 | ≤ 1.0 | ≤ 0.11 |
| Limit of Detection | ||||
| (LoD) | 0.7 | 0.08 | ≤ 1.0 | ≤ 0.11 |
| Limit of | ||||
| Quantitation (LoQ) | ||||
| ≤ 20% within-lab | ||||
| CV | 0.7 | 0.08 | ≤ 1.7 | ≤ 0.18 |
| Maximum Observed Result | Design Criteria | ||||
|---|---|---|---|---|---|
| INTRAOPERATIVE | |||||
| MODE | pg/mL | pmol/L | pg/mL | pmol/L | |
| Limit of Blank (LoB) | 0.5 | 0.05 | ≤ 1.0 | ≤ 0.11 | |
| Limit of Detection | |||||
| (LoD) | 0.8 | 0.08 | ≤ 1.0 | ≤ 0.11 |
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| Maximum Observed Result | Design Criteria | |||
|---|---|---|---|---|
| INTRAOPERATIVE | ||||
| MODE | pg/mL | pmol/L | pg/mL | pmol/L |
| Limit of Quantitation | ||||
| (LoQ) | ||||
| ≤ 20% within-lab CV | 0.8 | 0.08 | ≤ 1.7 | ≤ 0.18 |
Method Comparison:
A study based on CLSI EP09c, 3rd Edition using Weighted Deming regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
ROUTINE MODE:
| N | Concentration
Range*
(pg/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R |
|-----|------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 144 | 2.2 - 3278 | 0.97 | 0.96 - 0.98 | -0.23 | -0.33 - (-0.12) | 1.00 |
| N | Concentration
Range*
(pmol/L) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R |
|-----|-------------------------------------|-------|-----------------|-----------|-----------------------|---------------------------------|
| 144 | 0.23 - 347 | 0.97 | 0.96 - 0.98 | -0.024 | -0.035 - (-
0.013) | 1.00 |
INTRAOPERATIVE MODE:
| N | Concentrati
on Range*
(pg/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 116 | 2.3 - 3677 | 1.02 | 1.00 - 1.04 | -0.081 | -0.36 - 0.20 | 0.99 |
| N | Concentrati
on Range*
(pmol/L) | Slope | Slope
95% Cl | Intercept | Intercept
95% Cl | Correlation
Coefficient
R |
|-----|--------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 116 | 0.24 - 390 | 1.02 | 1.00 - 1.04 | -0.0086 | -0.038 -
0.021 | 0.99 |
*Range is Access 2 values
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access Intact PTH assay on the Dxl 9000 Access Immunoassay Analyzer (K232791) is substantially equivalent to Intact PTH assay on the Access Immunoassay System (K061190) as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.