The ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and Stage III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.

Device Description

The ARCHITECT CA 15-3 assay is a two-step immunoassay to determine the presence of DF3 reactive determinants in human serum or plasma, using Chemiluminescent Microparticle Immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex™. In the first step, sample, wash buffer and 115D8 coated paramagnetic microparticles are combined. DF3 reactive determinants present in the sample bind to the 115D8 coated microparticles. After washing, DF3 acridinium-labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of DF3 reactive determinants in the sample and the RLUs detected by the ARCHITECT i optical system.

AI/ML Overview

Acceptance Criteria and Device Performance Study for ARCHITECT® CA 15-3® Assay

This document summarizes the acceptance criteria and the study performed to demonstrate that the ARCHITECT® CA 15-3® Assay meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance characteristics, which serve as the acceptance criteria for the device. The reported performance for the ARCHITECT CA 15-3 Assay is compared against these criteria.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Reproducibility	Total precision %CV ≤ 8%	The total precision %CV of the ARCHITECT® CA 125 II™ assay was determined to be less than or equal to 8%. (Note: The document mentions "CA 125 II™ assay" here, but the 510(k) is for CA 15-3, implying this criterion is general for ARCHITECT assays or a typo. Assuming it applies to CA 15-3.)
Method Comparison	High correlation with predicate device (AxSYM CA 15-3 assay)	Passing-Bablok linear regression analysis comparing the ARCHITECT CA 15-3 assay to the AxSYM CA 15-3 assay yielded a correlation coefficient of 0.980, a slope of 0.94 (99% CI: 0.92, 0.97), and Y-axis intercept of -0.3 U/mL (99% CI: -0.9, 0.0).
Reference Ranges	Establishment of normal ranges in apparently healthy populations.	In 396 normal individual specimens, 99.0% of healthy female subjects had CA 15-3 assay values at or below 31.3 U/mL (mean = 13.0, SD = 7.0). Similar distributions were provided for pre-menopausal females (99% < 31.3 U/mL), post-menopausal females (99% < 31.3 U/mL), and males (98.5% < 31.3 U/mL).
Monitoring Effectiveness (Serial Specimens)	Demonstration of association between change in marker value and change in disease state for breast cancer patients. Positive Concordance, Negative Concordance, and Total Concordance with acceptable levels.	Total Concordance: 66.9% Positive Concordance (CA15-3 increase ≥9.575% with Progression): 75.7% Negative Concordance (CA15-3 <9.575% with No Progression): 64.5% Per-Patient Distribution (Total, 74 patients): - CA15-3 ≥9.575% & Progression: 36 patients - CA15-3 ≥9.575% & No Progression: 27 patients - CA15-3 <9.575% & Progression: 1 patient - CA15-3 <9.575% & No Progression: 10 patients Confidence intervals for per-patient estimates were also determined.

2. Sample Size Used for the Test Set and Data Provenance

Reproducibility (Precision):
- Sample Size: Five defibrinated plasma-based panel members were tested. Each was tested in replicates of two, at two separate times per day, for 20 days. This amounts to 5 samples * 2 replicates * 2 times/day * 20 days = 400 individual measurements.
- Data Provenance: The study was performed at Fujirebio Diagnostics, Inc. (FDI). It is a prospective study as samples were repeatedly tested under defined conditions.
Comparison Study:
- Sample Size: 402 serum specimens.
  - 250 serum specimens were from patients diagnosed with breast cancer (stage I through stage IV).
  - The remaining 152 specimens were presumably from other patient populations or healthy individuals to provide a broader range of concentrations.
- Data Provenance: Not explicitly stated, but implies clinical samples acquired for testing. Likely retrospective, as samples were "tested using" both assays, suggesting pre-existing specimens. Country of origin not specified.
Reference Ranges (Apparently Healthy Population):
- Sample Size: 396 normal individual specimens.
  - 99 healthy pre-menopausal females.
  - 100 healthy post-menopausal females.
  - 197 healthy males.
- Data Provenance: Not specified, but generally, reference range studies use prospectively collected healthy donor samples. Country of origin not specified.
Reference Ranges (Patient Groups - Various Diseases):
- Sample Size: 569 specimens from various disease states:
  - 120 Ovarian Cancer
  - 50 Colorectal Cancer
  - 50 Lung Cancer
  - 100 Breast Disease (Non-malignant)
  - 100 Ovarian Disease (Non-malignant)
  - 49 Urogenital Disease
  - 50 Pregnancy
  - 100 Hypertension/CHD
- Data Provenance: Not specified, but likely retrospective collection of patient samples. Country of origin not specified.
Breast Cancer Serial Specimens (Monitoring Effectiveness):
- Sample Size:
  - Patients: 74 evaluable breast cancer patients.
  - Observations: 377 evaluable observations (average 5.1 observations per patient).
  - Observation Pairs: 303 observation pairs were used for the 2x2 table analysis.
- Data Provenance: Likely retrospective collection of serial samples from breast cancer patients undergoing monitoring. The average age and stage distribution suggest these are patient cohorts from clinical practice. Country of origin not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This being an immunoassay for a biomarker, the "ground truth" is typically defined by established clinical diagnostic criteria, pathology, or disease progression status determined by a physician. The document does not describe the use of independent experts to establish ground truth in the same way an imaging or diagnostic AI system might for interpretation tasks.

For the Monitoring Effectiveness study, the "Change in Disease State" (Progression vs. No Progression) would be considered the ground truth. This is generally determined by attending clinicians based on a comprehensive assessment (imaging, clinical examination, pathology, other biomarkers, etc.). The document indicates "Stage was available from the charts for 61 women," implying physician diagnosis and staging. No specific number of experts or their qualifications for establishing this "ground truth" is provided, as it's assumed to be part of standard clinical practice.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used when multiple human readers interpret data to resolve disagreements and establish a consensus ground truth. For this type of immunoassay, the readouts are quantitative (U/mL), and the "ground truth" for disease status is derived from clinical outcomes rather than interpretation of the assay itself by multiple experts.

Therefore, no specific adjudication method for the test set is mentioned or appears applicable in the context of this device. The values generated by the device are objective measurements, and the clinical outcomes for ground truth are determined by standard medical practice.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or is applicable for this device. This is an immunoassay designed to quantitatively measure a biomarker, not to be interpreted by human readers in the same way as an imaging device. The device's output is a numerical value, not an image or data requiring human interpretation for diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes, a standalone performance study was conducted. The entire testing described (reproducibility, method comparison, reference ranges, and serial monitoring) evaluates the performance of the ARCHITECT CA 15-3 Assay in generating quantitative results for CA 15-3. The device operates as an automated system to produce these measurements. The "human-in-the-loop" component is the clinician's interpretation of these quantitative results in conjunction with other clinical methods for patient management, not in the direct operation or result generation of the assay itself.

7. Type of Ground Truth Used

Method Comparison: The ground truth for this comparison was the quantitative result provided by the predicate device, AxSYM CA 15-3 assay. This is a comparative "ground truth" rather than an absolute clinical outcome.
Reference Ranges: The ground truth was based on the health status (apparently healthy vs. various disease states) of the individuals from whom the specimens were collected, as determined by their medical history/diagnosis.
Monitoring Effectiveness (Serial Specimens): The ground truth was the "Change in Disease State" (Progression or No Progression) of the breast cancer patients. This would be determined by objective clinical assessments (e.g., imaging reports, biopsy results, clinical examination findings, and other physician observations) over time. This falls under outcomes data / clinical diagnosis.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. For an immunoassay, the development process involves reagent formulation, assay optimization, and calibration, which are typically iterative processes internal to the manufacturer. The data presented here are for validation and verification of the final commercial assay's performance.

9. How the Ground Truth for the Training Set was Established

Since a distinct "training set" and its associated ground truth for algorithmic development are not outlined in the provided 510(k) summary (as it's not an AI/ML-based diagnostic device in the modern sense), this question is not applicable here. The "ground truth" for calibrating the assay would be established using known concentrations of CA 15-3 antigen.

Summary

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5042732

DEC 2 2 2004

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.

The assigned 510(k) number is:

Submitter Information

Address:	Fujirebio Diagnostics, Inc.201 Great Valley ParkwayMalvern, PA 19355
Contact person:	Kimberly Peterson, (610) 240-3828
Summary preparation date:	September 30, 2004
Name of Device
Trade/Proprietary Name:	ARCHITECT® CA 15-3® Assay
Common/Usual Name:	CA 15-3 Assay
Classification Name:	System, Test, Immunological, Antigen, Tumor
Predicate Device

AxSYM® CA 15-3® Assay

Device Description

In the first step, sample, wash buffer and 115D8 coated paramagnetic microparticles are combined. DF3 reactive determinants present in the sample bind to the 115D8 coated microparticles. After washing, DF3 acridinium-labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the cresulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of DF3 reactive determinants in the sample and the RLUs detected by the ARCHITECT i *optical system.

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For additional information on system and assay technology, refer to the ARCHITECT i System Operations Manual, Section 3.

*i =immunoassay

Intended Use

Reagent Kit

The ARCHITECT CA 125 II assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CA 125 reactive determinants in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 II assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Calibrator Kit

The ARCHITECT CA 125 II Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of OC 125 defined antigen in human serum and Refer to the ARCHITECT CA 125 Il reagent package insert for additional plasma. information.

Control Kit

The ARCHITECT CA 125 II Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of OC 125 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 125 Il reagent package insert for additional information.

Statement of Substantial Equivalence

The ARCHITECT CA 15-3 Assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and Stage III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.

ARCHITECT CA 15-3 Assay kit is substantially equivalent to the AxSYM® CA 15-3° Assay manufactured by Abbott Laboratories. Both of the devices are IVD products and are indicated for the quantitative determination of CA 15-3 assay values (DF3 defined antigen) in human serum and plasma, as an aid in the management of Stage III and Stage III breast cancer patients.

A comparison of the features of the ARCHITECT CA 15-3 Assay device and the AxSYM CA 15-3 Assay follows.

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	Abbott LaboratoriesARCHITECT CA 15-3 Assay(Proposed Device)	Abbott LaboratoriesAxSYM® CA 15-3® Assay(Predicate Device)K963926
Device Type	In vitro diagnostic	In vitro diagnostic
Classification andProduct Code	Class II, MOI	Class II, MOI
Principle ofOperation	Chemiluminscent MicroparticleImmunoassay (CMIA)	Microparticle EnzymeImmunoassay (MEIA)
Product Usage	Clinical and Hospital laboratories	Clinical and Hospitallaboratories
Intended Use	The ARCHITECT CA 15-3 Assayis a chemiluminescentmicroparticle immunoassay(CMIA) for the quantitativedetermination of DF3 definedantigen in human serum andplasma on the ARCHITECT iSystem. The ARCHITECT CA15-3 assay is to be used as anaid in the management of StageII and Stage III breast cancerpatients. Serial testing for patientCA 15-3 assay values should beused in conjunction with otherclinical methods for monitoringbreast cancer.	The AXSYM CA 15-3 Assay isa microparticle enzymeimmunoassay (MEIA) for thequantitative measurement ofCA 15-3 assay values inhuman serum and plasma(EDTA) to aid in themanagement of Stage II andStage III breast cancerpatients. Serial testing forpatient CA 15-3 assay valuesshould be used in conjunctionwith other clinical methods formonitoring breast cancer.
Type of Specimen	Human serum or plasma (EDTA,Lithium Heparin, SodiumHeparin)	Human Serum or plasma(EDTA)
SpecimenCollection Method	Routine Phlebotomy Techniques	Routine PhlebotomyTechniques
Analyte Detected	Breast carcinoma-associatedmucin antigen encoded by theMUC 1 gene	Breast carcinoma-associatedmucin antigen encoded by theMUC 1 gene
Capture Antibody	115D8 mouse monoclonal	115D8 mouse monoclonal
Conjugate Antibody	DF3 mouse monoclonal	DF3 mouse monoclonal
Calibrators	6 levels (0 - 800 U/mL )	6 levels (0 - 250 U/mL)
Controls	2 levels (Low = 40 U/mL, High =250 U/mL)	2 levels (Low = 35 U/mL, High= 150 U/mL)
Interpretation ofResults	Standard Curve	Standard Curve

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Summary of Performance characteristics

Reproducibility:

Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Five defibrinated plasma based panel members (1, 2, 3, 4 and 5) were tested, in replicates of two, at two separate times per day, for 20 days. Testing was performed on 2 instruments (both instruments are located at FDI) using 2 lots of The total precision was determined by reagents and a single calibration per instrument. calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.

The total precision %CV of the ARCHITECT® CA 125 II™ assay was determined to be less than or equal to 8%.

Comparison Study

A total of 402 serum specimens, of which 250 serum specimens were from patients diagnosed with breast cancer (stage I through stage IV), were tested using the ARCHITECT CA 15-3 assay and the AxSYM CA 15-3 assay. Passing-Bablok linear regression analyses was performed on all specimens with concentration values within the dynamic range of both assays (0.0-1326.5 U/mL*) for the ARCHITECT CA 15-3 assay and (4.9-1621.9 U/mL*) for the AxSYM CA 15-3 Assay.

Passing-Bablok linear regression analysis comparing the ARCHITECT CA 15-3 assay to the AxSYM CA 15-3 assay yielded a correlation coefficient of 0.980, a slope of 0.94 (99% confidence interval of 0.92, 0.97), and Y-axis intercept of - 0.3 U/mL (99% confidence interval of -0.9, 0.0).

Reference Ranges:

Apparently Healthy Population:

The distribution of CA 15-3 assay values determined in 396 normal individual specimens is shown in the table below:

Distribution of ARCHITECT CA 15-3 Assay Values
	Number ofSubjects	0-31.3U/mL	31.4-60U/mL	60.1-120U/mL	>120U/mL
Apparently Healthy
Females (Pre Menopausal)	99	99.0	1.0	0.0	0.0
Females (Post Menopausal)	100	99.0	0.0	1.0	0.0
Males	197	98.5	1.5	0.0	0.0

In this study. 99.0% of the healthy female subjects had CA 15-3 assay values at or below 31.3 U/mL. (mean = 13.0, SD = 7.0)

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Patient Groups:

The distribution of CA 15-3 assay values determined in 569 specimens from various diseases is shown in the table below:

Distribution of ARCHITECT CA 15-3 Assay Values
	Percent (%)
	Number ofSubjects	0-31.3U/mL	31.4-60U/mL	60.1-120U/mL	>120U/mL
Malignant Conditions
Ovarian Cancer	120	76.7	13.3	4.2	5.8
Colorectal Cancer	50	96.0	4.0	0.0	0.0
Lung Cancer	50	78.0	14.0	4.0	4.0
NonMalignant Conditions
Breast Disease	100	97.0	3.0	0.0	0.0
Ovarian Disease	100	99.0	1.0	0.0	0.0
Urogenital Disease	49	84.0	16.0	0.0	0.0
Pregnancy	50	100.0	0.0	0.0	0.0
Hypertension/CHD	100	94.0	6.0	0.0	0.0

Breast Cancer Serial Specimens

This analysis is based on 74 evaluable patient's samples. There were a total of 377 evaluable observations. The average number of observations per patient is 5.1.

The average age of the women in this cohort at time of diagnosis was 48 years (Exact 95% Cl: 45.3 years to 48.9 years). Forty-seven percent of the women were post-menopausal at time of diagnosis. Stage was available from the charts for 61 women. Sixty-four percent of the cohort was eventy split between stage II with 23% of the woman having stage IV disease.

Association between Change in Marker Value and Change in Disease State:

A 2x2 table was constructed to show the association between a positive change in a patient's CA15-3 value and progression of the disease from one observation to the next. A positive change in CA15-3 is defined as an increase in the value that is at least 2.5 times greater than the total %CV of the test. For the test assay this value is 9.575%. The following Table (entitled "Distribution of W by V") presents the results for the 303 observation pairs in this study.

Three estimates of Concordance are given for the following Table.

Total Concordance: $C = \frac{50+153}{303}$ ×100 = 66.9% 303

133

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$$\text{Positive Consordance: } C_\star = \frac{50}{66} \times 100 = 75.7%$$

153 ×100 = 64.5% Negative Concordance: $C_ =$ 237

Distribution of W by V

	Change in Disease State (W)
Change in CA15-3 (V)	Progression	No Progression	Total
≥9.575%	50	84	134
<9.575%	16	153	169
Total	66	237	303

Per Patient Analysis:

The table below (entitled " Per Patient Distribution) demonstrates this distribution for the 74 patients in this study.

Per Patient Distribution
Change in CA15-3(V)	Progression	No Progression	Total
≥9.575%	36	27	63
<9.575%	1	10	11
Total	37	37	74

Per Patient Distribution

Estimates of per-patient concordances can be obtained. Confidence intervals for these estimates can be determined using the binomial distribution. The following table (entitled" Estimate of Per-Patient Positive, Negative and Total Concordance with 95% confidence Intervals) demonstrates the estimates and 95% confidence intervals about each estimate.

Estimate of Per-Patient Positive, Negative and Total Concordance With 95% Confidence intervals

Statistic	stimate	owerBound	Bound
			00 20100.0
			real and and the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first for the first th

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 2004

Ms. Kimberly M. Peterson Director, Clinical and Regulatory Affairs Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy. Malvern, PA 19355

K042732 Trade/Device Name: ARCHITECT® CA 15-3® Assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: MOI, JIT, JJX Dated: September 30, 2004 Received: October 4, 2004

Dear Ms. Peterson:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of quebtens on the price Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert H. Beckeysh

Robert L. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ARCHITECT® CA 15-3® Assay

Indications for Use:

ARCHITECT CA 15-3 Reagent Kit

The ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used prooms on the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.

ARCHITECT CA 15-3 Calibrator Kit

The ARCHITECT CA 15-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.

ARCHITECT CA 15-3 Control Kit

The ARCHITECT CA 15-3 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert H. Beckerf

Laboratory Devices

510(k) Number

Page 1 of Updated August 30, 2004

Regulation Number and Section

§ 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.