(241 days)
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No
The summary describes a standard immunoassay system for measuring TSH levels and does not mention any AI or ML components in the device description or performance studies.
No.
This device is for the quantitative determination of TSH levels, which is a diagnostic function, not a therapeutic one.
Yes
This device quantitatively determines Thyroid-Stimulating Hormone (TSH) levels in human serum and plasma, which is used to diagnose thyroid conditions.
No
The device description explicitly states that the system comprises the assay, calibrators, and Access Immunoassay analyzers, indicating the presence of hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of human thyroid-stimulating hormone (TSH) levels in human serum and plasma. This involves testing biological samples in vitro (outside the body).
- Device Description: The description details an "Access Immunoassay System" comprising an assay, calibrators, and analyzers for the quantitative determination of TSH in human serum and plasma. This is a typical setup for an in vitro diagnostic test.
- Performance Studies: The document includes detailed performance studies such as Method Comparison, Imprecision, Linearity, Limit of Detection, Analytical Specificity, and Expected Reference Intervals. These are standard types of studies performed to validate the performance of an in vitro diagnostic device.
- Predicate Device: The mention of a "predicate Access HYPERsensitive hTSH assay" further indicates that this device is being compared to an existing IVD.
All these elements strongly point to the device being an In Vitro Diagnostic.
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. This assay is capable of providing 3rd generation TSH results.
The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
JLW, JIS
Device Description
The Access TSH (3rd IS) Assay (standardized to WHO 3rd International Standard, 81/565), Access TSH (3rd IS) Calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of thyroid-stimulating hormone (thyrotropin, TSH, hTSH) in human serum and plasma.
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
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Indicated Patient Age Range
General Population (non-pregnant females and males) ages 21 and older, Pregnant females - 1st Trimester, Pregnant females - 2nd Trimester, Pregnant females - 3rd Trimester.
Intended User / Care Setting
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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)
Method Comparison: A comparison of 155 serum samples with TSH concentrations ranging from approximately 0.010 to 50.0 µIU/mL were run on both the Access TSH (3rd IS) assay and the predicate Access HYPERsensitive hTSH assay. The results were compared using Passing-Bablok regression and Pearson correlation with the predicate on the x-axis. The observed linear fit had a slope = 0.94 with 95% confidence interval of 0.92 to 0.97, an intercept = - 0.02 µIU/mL and a correlation coefficient (r) = 0.99 and a slope specification 0.95 ± 0.10.
Imprecision: Serum samples within-run imprecision ranged from 1.5 to 3.5 %CV, between-day imprecision ranged from 1.6 to 5.3 %CV, between-run imprecision ranged from 0.2 to 2.0 %CV, and total imprecision ranged from 3.1 to 6.3 %CV at all TSH concentrations. Serum samples within-run SD ranged from 0.0004 to 0.0007 µlU/mL, the between-day SD ranged from 0.0005 to 0.0012 µIU/mL, the between-run SD ranged from 0.0001 to 0.0004 µIU/mL, and the total SD ranged from 0.0008 to 0.0015 µIU/mL at TSH concentrations ≤ 0.02 µIU/mL. The TSH (3rd IS) assay exhibits total imprecision of less than or equal to 10% CV for concentrations greater than 0.02 µIU/mL and ≤ 0.0029 SD at concentrations ≤ 0.02 µIU/mL.
High-dose Hook Effect: The Access TSH (3rd IS) assay demonstrated no high-dose hook effect up to at least 1,000 µIU/mL in a serum sample.
Linearity: The Access TSH (3rd IS) assay has demonstrated to be linear across the range of the assay (0.01 to approximately 50.0 µIU/mL) in serum samples.
Dilution Recovery: The Access TSH (3rd IS) assay has been demonstrated to dilute recover across the range of the assay (0.01 to approximately 50 ulU/mL) in serum samples. Samples containing hTSH concentrations from approximately 50 µIU/mL to 500 µIU/mL can be diluted 10-fold with an average recovery of 100 ± 10%.
Analytical Specificity: There is no significant interference from total protein, bilirubin, hemoglobin, or triglycerides in serum samples. Additionally, substances similar in structure to hTSH, when added to two individual patient serum samples with approximate hTSH concentrations of 0.3 µIU/mL and 5.0 µIU/mL, showed no significant cross-reactivity.
Expected Reference Intervals: TSH concentrations were measured in human serum samples collected from apparently healthy, normal euthyroid male and non-pregnant female subjects and pregnant female populations, with approximately equal distribution across all three trimesters (as defined by the American Congress of Obstetricians and Gynecologists), using the Access TSH (3rd IS) assay in order to establish the central 97.5% reference interval.
Matrix Comparison: A comparison of seventy-nine (79) matched sets of serum (gel and no gel) and plasma (lithium-heparin) samples with TSH concentrations ranging from approximately 0.01 to 50 µlU/mL were compared using Passing-Bablok regression. The observed linear fit for serum (no gel) vs. serum (gel) had an estimated slope = 1.00 with a 95% confidence interval (CI) of 0.98 to 1.02. The observed linear fit for plasma vs. serum (gel) had an estimated slope =1.00 with a 95% Cl of 0.98 to 1.01. The observed linear fit for plasma vs. serum (no gel) had an estimated slope of 1.00, with a 95% Cl of 0.98 to 1.03.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Blank (LoB): The highest measurement result observed with no analyte present in a serum sample is
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2016
BECKMAN COULTER, INC. MICHAEL LORENZ, SENIOR ANALYST, REGULATORY AFFAIRS IMMUNODIAGNOSTIC DEVELOPMENT CENTER 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318-1361
Re: K153651
Trade/Device Name: Access TSH (3rd IS) Assay and Access TSH (3rd IS) Calibrators on the Access Immunoassay Systems Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW, JIS Dated: July 11, 2016 Received: July 13, 2016
Dear Mr. Lorenz:
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 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.
1
If you desire specific advice for your device on our labeling regulations (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" (21 CFR 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 yours,
Stayce Beck -S
For: 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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Indications for Use
510(k) Number (if known)
Device Name
Access TSH (3rd IS) Assay and Access TSH (3rd IS) Calibrators on the Access Immunoassay Systems
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. This assay is capable of providing 3rd generation TSH results.
The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.
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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Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
510(k) Summary K153651
Date Prepared: December 15, 2015 Date Updated: July 11, 2016 Date Updated: August 17, 2016
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact: Gerri Baglien (952) 368-7645 (952) 368-7610 (fax)
Angela Kilian Alternate Contact:
(952) 368-1330 (952) 368-7610 (fax)
Device Name
| Proprietary / Trade Name: | Access TSH (3rd IS) Assay and Access
TSH (3rd IS) Calibrators on the Access
Immunoassay Systems |
|---------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Thyroid stimulating hormone assay |
| Classification Name: | Thyroid stimulating hormone test system
(21 CFR 862.1690)
Secondary Calibrator (21CFR 862.1150) |
Predicate Device
Access HYPERsensitive hTSH assay and Access HYPERsensitive hTSH Calibrators Manufactured by Beckman Coulter, Inc.
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Device Description
The Access TSH (3rd IS) Assay (standardized to WHO 3rd International Standard, 81/565), Access TSH (3rd IS) Calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of thyroid-stimulating hormone (thyrotropin, TSH, hTSH) in human serum and plasma.
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.
The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroidstimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.
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| Parameter | Access TSH (3rd IS) Assay | Predicate Access
HYPERsensitive hTSH Assay |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Access HYPERsensitive
hTSH assay is a paramagnetic
particle, chemiluminescent
immunoassay for the
quantitative determination of
human thyroid-stimulating
hormone (thyrotropin, hTSH)
levels in human serum and
plasma using the Access
Immunoassay Systems. This
assay is capable of providing 3rd
generation (HYPERsensitive
hTSH( and/or 2nd generation
(Fast hTSH) results. |
| Analyte
Measured | Human thyroid-stimulating
hormone (thyrotropin, TSH,
hTSH) | Human thyroid-stimulating
hormone (TSH, thyrotropin,
hTSH) |
| Standardization | WHO 3rd International
Reference Preparation Thyroid
Stimulating Hormone, Human
(NIBSC Coded 81/565) | WHO 2nd International
Reference Preparation Thyroid
Stimulating Hormone, Human
(NIBSC Coded 80/558) |
| Technology | Sandwich immunoassay | Sandwich immunoassay |
| Format | Chemiluminescent | Chemiluminescent |
| Method | Automated | Automated |
| Calibration | Utilizes a stored calibration
curve | Utilizes a stored calibration
curve |
| Sample Type | Serum or plasma | Serum or plasma |
| Measuring Range | 0.01 – 50.0 µIU/mL | 0.01 – 100 µIU/mL |
| Stability | Stable at 2 to 10°C for 28 days
after initial use | Stable at 2 to 10°C 28 days
after initial use |
| Parameter | Access TSH (3rd IS)
Calibrators | Predicate Access
HYPERsensitive hTSH
Calibrators |
| Intended use | The Access TSH (3rd IS)
Calibrators are intended to
calibrate the Access TSH (3rd IS)
assay for the quantitative
determination of human thyroid-
stimulating hormone
(thyrotropin, TSH, hTSH) levels
in human serum and plasma
using the Access Immunoassay
Systems. | The Access HYPERsensitive
hTSH Calibrators are intended to
calibrate the Access TSH (3rd IS)
assay for the quantitative
determination of human thyroid-
stimulating hormone (thyrotropin,
TSH, hTSH) levels in human
serum and plasma using the
Access Immunoassay Systems. |
| Standardization | WHO 3rd International Reference
Preparation Thyroid Stimulating
Hormone, Human (NIBSC
Coded 81/565) | WHO 2nd International Reference
Preparation Thyroid Stimulating
Hormone, Human (NIBSC Coded
81/565) |
| Calibrator Levels | 6 levels
(0 $ \mu $ IU/mL, and approximately
0.050, 0.30, 3.0, 15.0, and 50.0 $ \mu $ IU/mL) | 6 levels
(0 $ \mu $ IU/mL, and approximately 0.1,
0.5, 4.0, 10.0, and 100.0 $ \mu $ IU/mL) |
| Calibrator Matrix | Bovine serum albumin | Bovine serum albumin |
| Calibration Curve
Stability | 28 days | 28 Days |
| Stability | Vials are stable at 2 to 10°C for
90 days after initial use. | Vials are stable 2 to 10°C until
expiration date stated on the label |
Comparison of Technological Characteristics to the Predicate (Assay)
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Comparison of Technological Characteristics to the Predicate
(Calibrators)
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Summary of Studies
Method Comparison: A comparison of 155 serum samples with TSH concentrations ranging from approximately 0.010 to 50.0 µIU/mL were run on both the Access TSH (3rd IS) assay and the predicate Access HYPERsensitive hTSH assay. The results were compared using Passing-Bablok regression and Pearson correlation with the predicate on the x-axis. The observed linear fit had a slope = 0.94 with 95% confidence interval of 0.92 to 0.97, an intercept = - 0.02 µIU/mL and a correlation coefficient (r) = 0.99 and a slope specification 0.95 ± 0.10
Imprecision: Serum samples within-run imprecision ranged from 1.5 to 3.5 %CV, between-day imprecision ranged from 1.6 to 5.3 %CV, between-run imprecision ranged from 0.2 to 2.0 %CV, and total imprecision ranged from 3.1 to 6.3 %CV at all TSH concentrations. Serum samples within-run SD ranged from 0.0004 to 0.0007 µlU/mL, the between-day SD ranged from 0.0005 to 0.0012 µIU/mL, the between-run SD ranged from 0.0001 to 0.0004 µIU/mL, and the total SD ranged from 0.0008 to 0.0015 µIU/mL at TSH concentrations ≤ 0.02 µIU/mL. TThe TSH (3rd IS) assay exhibits total imprecision of less than or equal to 10% CV for concentrations greater than 0.02 µIU/mL and ≤ 0.0029 SD at concentrations ≤ 0.02 µIU/mL.
High-dose Hook Effect: The Access TSH (3rd IS) assay demonstrated no high-dose hook effect up to at least 1,000 µIU/mL in a serum sample.
Linearity: The Access TSH (3rd IS) assay has demonstrated to be linear across the range of the assay (0.01 to approximately 50.0 µIU/mL) in serum samples.
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Dilution Recovery: The Access TSH (3rd IS) assay has been demonstrated to dilute recover across the range of the assay (0.01 to approximately 50 ulU/mL) in serum samples. Samples containing hTSH concentrations from approximately 50 µIU/mL to 500 µIU/mL can be diluted 10-fold with an average recovery of 100 ± 10%.
Limit of Blank (LoB): The highest measurement result observed with no analyte present in a serum sample is