(196 days)
No
The description focuses on the immunoassay technology and the automated analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an "in vitro diagnostic device" used for quantitative, semiquantitative, or qualitative determination of various analyte concentrations in human body fluids, specifically for measuring TSH levels to aid in the diagnosis of thyroid or pituitary disorders. This indicates it is for diagnostic purposes, not for treating or rehabilitating a condition, which is characteristic of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Access TSH (3rd IS) assay" is used in the "diagnosis of thyroid or pituitary disorders" and that the "DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device."
No
The device description clearly outlines a physical immunoassay kit (reagents) and a physical analyzer instrument (DxI 9000 Access Immunoassay Analyzer), indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is for the "quantitative determination of human thyroid-stimulating hormone... in human serum and plasma". It also mentions that these measurements "are used in the diagnosis of thyroid or pituitary disorders." This clearly indicates the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description of both the Access TSH (3rd IS) assay and the DxI 9000 Access Immunoassay Analyzer mentions they are used for determining analyte concentrations in "human body fluids".
- DxI 9000 Access Immunoassay Analyzer Description: This description explicitly states that the analyzer "is an in vitro diagnostic device".
- Predicate Device: The predicate device listed, K153651 Access TSH (3rd IS) Assay, is also an IVD.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of any tissue or organ for transplantation.
N/A
Intended Use / Indications for Use
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.
The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Product codes (comma separated list FDA assigned to the subject device)
JLW, JJE
Device Description
Access TSH (3rd IS) assay is a two-site immunoenzymatic ("sandwich") assay. The Access TSH (3rd IS) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators and wash buffer.
The DxI 9000 Access Immunoassay Analyzer is a fully automated, continuous, random-access sample processing and analysis instrument. The DxI 9000 Access Immunoassay Analyzer uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
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
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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: A method comparison study was performed to compare the Access TSH (3rd IS) assay on Dxl 9000 to the predicate device. A total of one hundred and eleven (111) serum samples falling within the measuring range of the Access TSH (3rd IS) assay were evaluated. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10.
Imprecision: On the Dxl 9000 Access Immunoassay Analyzer, within-laboratory (total) % CV ranged from 2.5% to 4.5%, for TSH concentrations > 0.02 µlU/mL. The within-laboratory (total) SD ranged from 0.0007 to 0.0014 for TSH concentrations ≤ 0.02 mlU/mL.
Reproducibility: The Access TSH (3rd IS) assay is designed to meet the requirements for reproducibility on the Dxl 9000 Access Immunoassay Analyzer with an SD ≤ 0.0038 for values ≤ 0.02 ulU/mL and CV 0.02 ulU/mL.
Linearity: The Access Total TSH (3rd IS) assay is linear on the Dxl 9000 Immunoassav Analyzer throughout the analytical measuring interval of approximately 0.01 - 50.0 µIU/mL (mIU/L).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method Comparison: Slope 1.06, Slope 95% CI 1.04, 1.07, Intercept -0.019, Intercept 95% CI -0.10, -0.0037, R2 1.00.
Imprecision: Within-laboratory (total) % CV ranged from 2.5% to 4.5%, for TSH concentrations > 0.02 µlU/mL. The within-laboratory (total) SD ranged from 0.0007 to 0.0014 for TSH concentrations ≤ 0.02 mlU/mL.
Limit of Blank (LoB): 0.002 µIU/mL
Limit of Detection (LoD): 0.003 µ/U/mL
Limit of Quantitation (LoQ): 0.001 µlU/mL (reported as 0.003 µIU/mL to align with LoD).
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.
Access TSH (3rd IS) Assay, 510(k) Number K153651, Access 2 Immunoassay System, 510(k) Number K121214
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
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
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November 10, 2022
Beckman Coulter, Inc. Kuljeet Kaur Regulatory Affairs Manager 1000 Lake Hazeltine Drive Chaska, MN 55318
Re: K221225
Trade/Device Name: Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid Stimulating Hormone Test System Regulatory Class: Class II Product Code: JLW, JJE Dated: August 30, 2022 Received: August 30, 2022
Dear Kuljeet Kaur:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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
Digitally signed by
Paula Caposino -S
Caposino -S Date: 2022.11.10
10:41:41 -05'00'
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221225
Device Name
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Indications for Use (Describe)
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.
The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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: K221225
Date Prepared: November 09, 2022
Submitter Name and address Beckman Coulter, Inc 1000 Lake Hazeltine Drive Chaska, MN 55318
| Primary Contact: | Alternate Contact: |
|---|---|
| Kuljeet Kaur | Kate Oelberg |
| Regulatory Affairs Manager | Senior Staff Quality and Regulatory Affairs |
| Email: kkaur@beckman.com | Email: kmoelberg@beckman.com |
| Phone: (952) 465-1914 | Phone: (612)-431-7315 |
Trade Name: Access TSH (3rd IS) Assay Common Name: Thyroid stimulating hormone assay Classification Regulation: 21 CFR 862.1690 Classification Product Code: JLW
Trade Name: Dxl 9000 Access Immunoassay Analyzer Common Name: Discrete photometric chemistry analyzer for clinical use Classification Name: Discrete photometric chemistry analyzer for clinical use Classification Regulation:21 CFR 862.2160 Classification Product Code: JJE
Predicate Devices: Access TSH (3rd IS) Assay, 510(k) Number K153651 Access 2 Immunoassay System, 510(k) Number K121214
4
Device Description
Access TSH (3rd IS) assay is a two-site immunoenzymatic ("sandwich") assay. The Access TSH (3rd IS) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators and wash buffer.
The Dxl 9000 Access Immunoassay Analyzer is a fully automated, continuous, random-access sample processing and analysis instrument. The Dxl 9000 Access Immunoassay Analyzer uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Intended Use
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.
The Dxl 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Comparison Tables:
Comparison of TSH (3rd IS) on Dxl 9000 to the predicate (Assay)
| System
Attribute /
| Characteristic | TSH (3rd IS) | TSH (3rd IS) K153651 |
|---|---|---|
| Intended Use | The Access TSH (3rd IS) assay is a paramagnetic | |
| particle, chemiluminescent immunoassay for the | ||
| quantitative determination of human thyroid- | ||
| stimulating hormone (thyrotropin, TSH, hTSH) levels | ||
| in human serum and plasma using the Access | ||
| Immunoassay Systems. This assay is capable of | ||
| providing 3rd generation TSH results. | Same | |
| Analyte | ||
| Measured | Human thyroid-stimulating hormone | |
| (thyrotropin, TSH, hTSH) | Same | |
| Standardization | WHO 3rd International Reference | |
| Preparation Thyroid | ||
| Stimulating Hormone, Human (NIBSC | ||
| Coded 81/565) | Same | |
| Technology | Sandwich immunoassay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration | |
| curve | Same | |
| Sample Type | Serum or plasma | Same |
| Measuring | ||
| Range | 0.01 – 50.0 µIU/mL | Same |
5
| System
Attribute /
| Characteristic | TSH (3rd IS) | TSH (3rd IS) K153651 |
|---|---|---|
| Stability | Stable at 2 to 10°C for 28 days after initial use | Same |
| Reagent Pack | ||
| formulation and | ||
| packaging | Access Reagent Pack formulation and packaging. | Same |
| Instrument | Dxl 9000 Access Immunoassay Analyzer | UniCel Dxl 800 |
| Immunoassay System | ||
| Substrate | Lumi-Phos PRO substrate | Access Substrate |
| Reagent | ||
| Configurations | Two configurations: |
- 200 determinations, 2 packs, 100 tests/pack (predicate and candidate device)
- 400 determinations, 2 packs, 200 tests/pack (candidate only) | One Configuration:
200 determinations, 2
packs,
100 tests/pack |
Comparison of Technological Characteristics to the Predicate (Instrument)
| System
Attribute /
Characteristic | Dxl 9000 Access Immunoassay Analyzer | Predicate Access 2 Immunoassay
System K121214 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Dxl 9000 Access Immunoassay
Analyzer is an in vitro diagnostic
device used for the quantitative, semi-
quantitative, or qualitative
determination of various analyte
concentrations found in human body
fluids. | The Access 2 system is an in vitro
diagnostic device used for the
quantitative, semi-quantitative, or
qualitative determination of various
analyte concentrations found in
human body fluids. |
| Signal Source | Photons generated by chemiluminescent
substrate reacting
with alkaline phosphatase. | Same |
| Signal Detector | Photomultiplier tube (PMT) | Same |
| Data Analysis | Internal data reduction methods via
microcomputer | Same |
| Data Output | Digital display and PDF file creation | Digital display and printed alpha-
numeric hard copy |
| Temperature
Control | The following modules are temperature
controlled:
• Reaction build and reaction
incubation
• Substrate reaction zone
• Reagent storage
• Sample aliquot storage
• Reagent pipettors
• Dispense probes | The following modules are
temperature controlled:
• Reaction incubation
• Substrate reaction zone
• Reagent storage |
6
| Sample
Loading
| Capacity | 133 sample containers | 60 sample containers |
|---|---|---|
| Sample | ||
| Storage | ||
| Capacity (on- | ||
| board) | 268 sample vessels | None |
| Reagent | ||
| Capacity | 50 Access Reagent packs on board | 24 Access Reagent packs on board. |
| Throughput | ||
| (Maximum | ||
| tests/hour) | Approximately 450 | Approximately 100 |
| Number of | ||
| Reagent | ||
| Pipettors | Four | One |
Summary of studies:
Method Comparison: A method comparison study was performed to compare the Access TSH (3rd IS) assay on Dxl 9000 to the predicate device. A total of one hundred and eleven (111) serum samples falling within the measuring range of the Access TSH (3rd IS) assay were evaluated. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10.
| No. of
samples
(N) | Access 2 Variable
Range Concentration
(ulU/mL) | Slope | Slope 95%
CI | Intercept | Intercept 95%
CI | R2 |
|--------------------------|------------------------------------------------------|-------|-----------------|-----------|---------------------|------|
| 111 | 0.01, 47 | 1.06 | 1.04, 1.07 | -0.019 | -0.10, -0.0037 | 1.00 |
Imprecision: On the Dxl 9000 Access Immunoassay Analyzer, within-laboratory (total) % CV ranged from 2.5% to 4.5%, for TSH concentrations > 0.02 µlU/mL. The within-laboratory (total) SD ranged from 0.0007 to 0.0014 for TSH concentrations ≤ 0.02 mlU/mL.
| Concentration (ulU/mL) | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within-
Laboratory
(Total) | | |
|------------------------|----|-------------------------------|--------|-------------|--------|-------------|--------|----------------------------------|--------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 0.022 | 0.0012 | 5.5 | 0.0003 | 1.5 | 0.0006 | 2.8 | 0.0014 | 6.4 |
| Sample 2 | 80 | 0.36 | 0.009 | 2.6 | 0.007 | 2.0 | 0.008 | 2.3 | 0.014 | 4.0 |
| Sample 3 | 80 | 4.7 | 0.12 | 2.5 | 0.06 | 1.3 | 0.07 | 1.4 | 0.15 | 3.2 |
| Sample 5 | 80 | 12 | 0.4 | 3.8 | 0.0 | 0.1 | 0.2 | 2.1 | 0.5 | 4.3 |
| Sample 4 | 80 | 46 | 1.0 | 2.1 | 0.3 | 0.7 | 0.8 | 1.8 | 1.3 | 2.8 |
7
Reproducibility: The Access TSH (3rd IS) assay is designed to meet the requirements for reproducibility on the Dxl 9000 Access Immunoassay Analyzer with an SD ≤ 0.0038 for values ≤ 0.02 ulU/mL and CV 0.02 ulU/mL.
| Concentration (ulU/mL) | Repeatability
(Within-run) | Between-day | Between -
instrument | Reproducibility | | | | | | |
|------------------------|-------------------------------|-------------|-------------------------|-----------------|--------|-----|--------|-----|--------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 75 | 0.024 | 0.0006 | 2.6 | 0.0004 | 1.8 | 0.0006 | 2.5 | 0.0010 | 4.0 |
| Sample 2 | 75 | 0.37 | 0.012 | 3.3 | 0.010 | 2.8 | 0.000 | 0.0 | 0.016 | 4.3 |
| Sample 3 | 75 | 4.8 | 0.11 | 2.3 | 0.14 | 2.8 | 0.04 | 0.7 | 0.18 | 3.7 |
| Sample 5 | 75 | 12 | 0.2 | 2.1 | 0.2 | 2.0 | 0.3 | 2.4 | 0.5 | 3.8 |
| Sample 4 | 75 | 46 | 1.1 | 2.4 | 0.5 | 1.1 | 1.0 | 2.1 | 1.6 | 3.4 |
Linearity: The Access Total TSH (3rd IS) assay is linear on the Dxl 9000 Immunoassav Analyzer throughout the analytical measuring interval of approximately 0.01 - 50.0 µIU/mL (mIU/L).
Limit of Blank (LoB): The LoB for TSH (3rd IS) is 0.002 µIU/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The LoD estimate for the TSH (3rd IS) assav is 0.003 w/U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The maximum LoQ determined for the TSH (3w/S) assay is 0.001 µlU/mL on Dxl 9000 Access Immunoassay Analyzer). 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 µIU/mL to align with LoD.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's TSH (3rd IS) Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access TSH (3rd IS) Assay on the Access 2 Immunoassay System 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.