(529 days)
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
Access Thyroqlobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent /metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidinand coupled to biotinylated mouse monoclonalantithyroglobulin antibodies, suspended in a TRIS buffer withprotein (bovine), < 0.1% sodium azide, and 0.1% ProClin**300. |
| R1b: | Mouse monoclonal anti-thyroglobulin-alkaline phosphatase(bovine) conjugate in a TRIS buffer with protein (bovine,murine), < 0.1% sodium azide, and 0.1% ProClin 300. |
| R1c: | HEPES buffer with protein (bovine and mouse), < 0.1% sodiumazide, and 0.5% ProClin 300. |
The provided text describes the Beckman Coulter Access Thyroglobulin assay, a chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum. This device is intended to aid in monitoring for persistent or recurrent/metastatic differentiated thyroid cancer (DTC) in patients who have undergone thyroid surgery and lack serum thyroglobulin antibodies.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance for all aspects. Instead, acceptance criteria are generally mentioned within the description of each study. Below is a compilation of the criteria and reported performance for key studies.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R ≥ 0.90 and slope 1.00 ± 0.09 | Met (R and slope not explicitly provided but stated as met) |
| High-dose Hook Effect | No high-dose hook effect | No high-dose hook effect at concentrations up to at least 40,000 ng/mL |
| Reference Range | Linear across the range of the assay | Linear across the range of the assay (0.1 to approximately 500 ng/mL) |
| Limit of Blank (LoB) | ≤ 0.03 ng/mL | 0.02 ng/mL |
| Limit of Detection (LoD) | ≤ 0.05 ng/mL | 0.05 ng/mL |
| Limit of Quantitation (LoQ) | ≤ 0.1 ng/mL | 0.05 ng/mL |
| Analytical Specificity (Cross-reactivity) | Change in concentration between diluent control and test samples within ± 10% | No significant cross-reactivity for T3, T4, TBG, TSH |
| Analytical Specificity (Interference) | Change in concentration between diluent control and test samples within <± 10% | No significant interference observed, including with biotin at 3510 ng/mL |
Note: For Imprecision and Reproducibility, specific acceptance criteria (e.g., maximum allowable %CV) are not explicitly stated. The tables provide the observed performance metrics (SD, %CV) and imply that these are acceptable.
2. Sample size used for the test set and the data provenance
- Method Comparison: 102 serum samples.
- Imprecision: Not explicitly stated as a general sample count; involved multiple samples (6 different samples with varying concentrations) run in duplicate over 20 days.
- Reproducibility:
- Study 1: 2 samples run in 3 replicates.
- Study 2: 3 samples run in 5 replicates.
- High-dose Hook Effect: Not specified how many samples or what types were used, but concentrations up to 40,000 ng/mL were tested.
- Linearity: Serum samples were used across the assay range.
- Dilution Recovery: Serum samples were used across and above the assay range.
- Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ): Not explicitly stated how many individual samples were used for these studies, but they were determined based on specific testing procedures.
- Analytical Specificity (Cross-reactivity): Serum patient samples at two thyroglobulin concentrations (approx. 20 ng/mL and 100 ng/mL) were used. The number of unique patient samples is not specified.
- Analytical Specificity (Interference): Patient serum samples containing two levels of Thyroglobulin (approx. 25.0 ng/mL and 100.0 ng/mL) were used. The number of unique patient samples is not specified.
Data Provenance: The document does not specify the country of origin for the data or whether the samples were collected retrospectively or prospectively. It consistently refers to the use of "human serum" or "patient serum samples."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device (an in-vitro diagnostic immunoassay). The ground truth for such assays is established by the intrinsic biochemical properties and analytical performance of the assay itself (e.g., accuracy against reference methods, precision, detection limits using reference standards or well-characterized samples), rather than expert interpretation of images or clinical cases.
4. Adjudication method for the test set
This information is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., radiology for AI-assisted diagnosis), where there might be disagreement among experts. For an immunoassay, the results are quantifiable and objective measurements, not subject to subjective adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable to this device. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human readers are interpreting cases. The Access Thyroglobulin assay is an automated laboratory test that directly measures a biomarker, without a "human reader" component in the interpretation of the primary data within the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Access Thyroglobulin assay is a standalone device in the sense that it performs the measurement algorithmically via its chemiluminescent immunoassay system without direct human interpretation of the raw signal output. The "algorithm only" performance is what these analytical studies (imprecision, linearity, LoD, etc.) demonstrate. Human involvement is in sample preparation, loading, and interpretation of the final quantitative result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on analytical performance characteristics established through:
- Reference methods or predicate device comparison (for method comparison study).
- Use of well-characterized samples or reference materials (e.g., for LoB, LoD, LoQ, linearity).
- Known concentrations of potential cross-reactants and interferents (for analytical specificity studies).
- Statistical analysis of repeated measurements (for imprecision and reproducibility).
8. The sample size for the training set
This document describes the performance studies for a modificated device that is compared to a previously cleared predicate and is not a new AI/machine learning device that typically involves a distinct "training set." The studies mentioned are validation studies, not training. Therefore, a specific "training set sample size" is not applicable in the context of this submission. The development and optimization of the immunoassay reagents and protocols would have occurred during the assay's development, but this document focuses on its validation.
9. How the ground truth for the training set was established
As there is no "training set" in the context of an AI/machine learning model for this immunoassay submission, the question of how its ground truth was established is not applicable. The "ground truth" for the performance studies described in this document is derived from established analytical methods, reference materials, and the comparative performance against the predicate device.
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September 15, 2023
Beckman Coulter, Inc. Adam Viitala Senior Manager Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K220972
Trade/Device Name: Access Thyroglobulin Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: MSW Dated: January 26, 2023 Received: January 26, 2023
Dear Adam Viitala:
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
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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,
Ying Mao-S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology 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) K220972
Device Name Access Thyroglobulin
Indications for Use (Describe)
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
| 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 Tg 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 K220972
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 246-1860
Contact Person:
Adam Viitala 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: +1 (520) 496-4517
Alternate Contact:
Muhammad Sheikh Office Phone: (952) 368-1142
Date Prepared:
September 14, 2023
Device Name:
Proprietary / Trade Name: Access Thyroglobulin Common Name: Thyroglobulin Chemiluminescence Immunoassay Classification Description: Tumor-associated antigen immunological test system Classification Regulation: 21 CFR 866.6010 Classification Product Code: MSW
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Predicate Device:
The modified Access Thyroglobulin assay claims substantial equivalence to previously cleared Access Thvroglobulin assay. FDA 510(k) Number K002905, cleared October 19, 2000.
Device Description:
Access Thyroqlobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent /metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidinand coupled to biotinylated mouse monoclonalantithyroglobulin antibodies, suspended in a TRIS buffer withprotein (bovine), < 0.1% sodium azide, and 0.1% ProClin**300. |
| R1b: | Mouse monoclonal anti-thyroglobulin-alkaline phosphatase(bovine) conjugate in a TRIS buffer with protein (bovine,murine), < 0.1% sodium azide, and 0.1% ProClin 300. |
| R1c: | HEPES buffer with protein (bovine and mouse), < 0.1% sodiumazide, and 0.5% 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:
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid
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cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
Comparison to the Predicate:
The modified device and previously cleared predicate device are compared below.
| Characteristic | Predicate DeviceAccess Thyroglobulin (K002905) | Modified DeviceAccessThyroglobulin |
|---|---|---|
| Intended Use | The Access Thyroglobulin (Tg) assay is aparamagnetic particle, chemiluminescentimmunoassay for the quantitativedetermination of thyroglobulin levels inhuman serum and plasma using the AccessImmunoassay Systems. This device isintended to aid in monitoring for the presenceof local and metastatic thyroid tissue inpatients who have had thyroid gland ablation(using thyroid surgery with or withoutradioactivity) and who lack serumthyroglobulin antibodies. | Access Thyroglobulinassay is aparamagnetic particle,chemiluminescentimmunoassay for thequantitativedetermination ofthyroglobulin levels inhuman serum usingthe AccessImmunoassaySystems. This deviceis intended to aid inmonitoring for thepresence of persistentor recurrent/metastaticdisease in patientswho have differentiatedthyroid cancer (DTC)and have had thyroidsurgery (with or withoutablative therapy), andwho lack serumthyroglobulinantibodies. |
| AnalyteMeasured | Thyroglobulin | Same |
| Technology | Sandwich immunoassay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Sample Type | Human serum or plasma | Human serum |
| AssayThroughput | Approximately 42 Minutes | Same |
| Sample Volume | 40 uL | Same |
| MeasuringRange | 0.1 - 500 ng/mL | Same |
| Assayarchitecture | Biotinylated mouse monoclonalantithyroglobulin antibodies not pre-coupledto paramagnetic particles coated withstreptavidin | Biotinylated mousemonoclonalantithyroglobulinantibodies pre-coupled toparamagnetic particlescoated with streptavidin |
| Antibodies | Mouse monoclonal antibodies | Same |
| BiotinInterference | Specimens with biotin concentrations ≤ 10ng/mL demonstrated non-significant bias (≤10%) in results. Biotin concentrations > 10ng/mL can lead to significant (> 10%)negative bias in Thyroglobulin results. | No significantinterference (≤± 10%)observed in samplescontaining up to 3,510ng/mL of biotin. |
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Summary of Studies:
Method Comparison: A comparison of 102 serum samples with thyroglobulin concentrations within the assay's measuring range were run on both the modified Access Thyroglobulin assay and the predicate currently marketed Access Thyroglobulin assay. The results were compared using Passing-Bablok reqression and Pearson's correlation with the predicate on the x-axis. The results of the method comparison study met the acceptance criteria of R ≥ 0.90 and slope 1.00 ± 0.09.
Imprecision: A study based on CLSI EP05-A3 performed on an Access Immunoassay System tested multiple samples in duplicate in 2 runs per day for 20 days. The representative imprecision data is provided in the following table.
| Sample | N | Mean(ng/mL) | Within-Run | Between-Run | Between-Day | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| 1 | 80 | 0.11 | 0.01 | 8.4 | 0.01 | 4.7 | 0.00 | 0.0 | 0.01 | 9.6 |
| 2 | 80 | 0.17 | 0.01 | 6.2 | 0.02 | 14.0 | 0.01 | 4.3 | 0.03 | 15.9 |
| 3 | 80 | 4.5 | 0.09 | 2.1 | 0.06 | 1.3 | 0.05 | 1.0 | 0.12 | 2.6 |
| 4 | 80 | 21 | 0.4 | 1.9 | 0.0 | 0.0 | 0.2 | 0.9 | 0.5 | 2.2 |
| 5 | 80 | 133 | 2.2 | 1.6 | 1.7 | 1.2 | 0.0 | 0.0 | 2.7 | 2.1 |
| 6 | 80 | 431 | 7.2 | 1.7 | 8.5 | 2.0 | 18.4 | 4.3 | 21.5 | 5.0 |
Reproducibility: Two reproducibility studies based on CLSI EP05-A3 performed on the Access Immunoassay System tested multiple samples in replicates of 3 or 5 over a 5 day period of time. Study 1 consisted of 3 replicates of 2 samples tested with 2 runs per day for 5 days on 3 instruments. Study 2 consisted of 5
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replicates of 3 samples with 3 runs per day over 5 days one 1 instrument. The representative reproducibility data is provided in the following table.
| Mean | Repeatability(within-run) | Between-day | Between-instrument | Reproducibility | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study | (ng/mL) | N | SD(ng/mL) | %CV | SD(ng/mL) | %CV | SD(ng/mL) | %CV | SD(ng/mL) | % CV |
| 1 | 4.3 | 90 | 0.07 | 1.7 | 0.04 | 1.0 | 0.10 | 2.3 | 0.15 | 3.6 |
| 20 | 90 | 0.27 | 1.3 | 0.00 | 0.0 | 0.57 | 2.8 | 0.74 | 3.6 | |
| 2 | 0.48 | 75 | 0.01 | 2.9 | 0.01 | 2.2 | 0.01 | 2.0 | 0.02 | 4.2 |
| 136 | 75 | 2.44 | 1.8 | 1.43 | 1.1 | 3.01 | 2.2 | 4.13 | 3.0 | |
| 446 | 75 | 10.74 | 2.4 | 8.15 | 1.8 | 0.00 | 0.0 | 13.48 | 3.0 |
High-dose Hook Effect: The Access Thyroglobulin assay demonstrated no highdose hook effect at concentrations up to at least 40,000 ng/mL.
Linearity: The Access Thyroglobulin assay has been demonstrated to be linear across the range of the assay (0.1 to approximately 500 ng/mL) in serum samples.
Dilution Recovery: The Access Thyroglobulin assay has been demonstrated to dilute recover across and above the range of the assay in serum samples.
Limit of Blank (LoB): The Access Thyroglobulin assay was designed to have a Limit of Blank of ≤ 0.03 ng/mL. In one study, LoB testing determined the LoB for Access Thyroglobulin to be 0.02 ng/mL.
Limit of Detection (LoD): The Access Thyroglobulin assay was designed to have a Limit of Detection (LOD) of ≤ 0.05 ng/mL in serum samples. In one study, LoD testing determined the LoD for Access Thyroglobulin to be 0.05 ng/mL.
Limit of Quantitation (LoQ): The Access Thyroqlobulin assay was designed to have a Limit of Quantitation (LOD) of ≤ 0.1 ng/mL in serum samples. In one study, the LoQ for Access Thyroglobulin was determined to be 0.05 ng/mL.
Analytical Specificity: Potential cross-reactive substances were added to serum patient samples at two concentrations of thyroglobulin (approximately 20 ng/mL and 100 ng/mL). Stock solutions of potential cross-reactants were prepared and added directly to the serum in no more than 5% (v/v) final concentration. Control samples were prepared in the same manner without the cross-reactant added. Testing of 3,3',5-Triiodo-L-thyronine (T3), L-Thyroxine (T4), Thyroxine Binding Globulin (TBG) and Thyroid Stimulating Hormone (TSH) with Access Thyroglobulin found that there is no significant cross-reactivity, as defined by a change in concentration between the diluent control and the test samples within ± 10%.
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Potential interferents were tested at one concentration and compared to control samples without potential interferents. The results were reported as a percent difference between test and control sample. Testing was completed on patient serum samples containing two levels of Thyroglobulin at clinically relevant concentrations of approximately 25.0 ng/mL and 100.0 nq/mL. Testing of all potential interferents, including biotin at a concentration of 3510 ng/mL, with Access Thyroqlobulin found that there is no significant interference, as defined by a change in concentration between the diluent control and the test samples within <± 10%.
Conclusion:
The modified device has the same intended use and fundamental scientific technology as the predicate device. The modified device is as safe and effective as the predicate device, as demonstrated through verification testing.
The information provided in this submission demonstrates that the modified device is substantially equivalent to the predicate device.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.