Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a standard immunoassay technology (CMIA) and statistical analysis of results, with no mention of AI or ML algorithms.

Therapeutic

No
The device is an in vitro diagnostic assay used to monitor response to therapy for ovarian cancer patients, not to treat the cancer itself.

Diagnostic

Yes

The device is intended "as an aid in monitoring response to therapy for patients with epithelial ovarian cancer," which directly contributes to the diagnosis and management of a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a Chemiluminescent Microparticle Immunoassay (CMIA) which involves physical reagents (microparticles, conjugate, solutions) and a physical instrument (ARCHITECT i System) to measure relative light units (RLUs). This is a hardware-based assay, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of CA 125 reactive determinants in human serum and plasma." This involves testing biological samples (serum and plasma) in vitro (outside the body).
Device Description: The description details a "Chemiluminescent Microparticle Immunoassay (CMIA)" which is a laboratory technique used to measure substances in biological samples.
Performance Studies: The performance studies describe testing of "human serum and plasma" specimens and comparing results to a predicate device, which is typical for IVD validation.
Intended User/Care Setting: The intended users are "Clinical and Hospitals laboratories," which are settings where in vitro diagnostic testing is performed.

All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ARCHITECT CA 125 II Reagent Kit: The ARCHITECT CA 125 Il 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.

ARCHITECT CA 125 Il 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 plasma. Refer to the ARCHITECT CA 125 II reagent package insert for additional information.

ARCHITECT CA 125 II 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 II reagent package insert for additional information.

Product codes

LTK, JIT, JJX

Device Description

The ARCHITECT CA 125 II assay is a two-step immunoassay to determine the presence of OC125 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 of the ARCHITECT CA 125 II assay, sample and OC125 coated paramagnetic microparticles are combined. CA 125 reactive determinants present in the sample bind to the OC125 coated microparticles. After washing, M11 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 CA 125 reactive determinants in the sample and the RLUs detected by the ARCHITECT i optical system.

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

Clinical and Hospitals laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Reproducibility:
Precision was determined using the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Three defibrinated plasma panel members were tested using two lots of reagents, in replicates of two, at two separate times per day, for 20 days on 2 separate instruments. Each reagent lot used a single calibration curve throughout the study.
The total precision was determined by 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 10%.

Comparison Study:
Study Type: Comparison Study.
Sample Size: 280 serum specimens (120 of which were from Ovarian cancer Patients).
Key Results: Passing-Bablok linear regression analysis comparing the ARCHITECT CA 125 II assay to the AxSYM CA 125 assay yielded a correlation coefficient of 0.985, a slope of 1.06 (99% confidence interval of 1.03, 1.11), and Y-axis intercept of 4.0 U/mL (99% confidence interval of 2.0, 4.9).

Reference Ranges: Apparently Healthy Population:
Study Type: Distribution of CA 125 II assay values in normal individuals.
Sample Size: 196 normal individual specimens.
Key Results: 94.4% of healthy female subjects had CA 125 II assay values at or below 35.0 U/mL (mean = 16.4, SD = 13.0).

Reference Ranges: Patient Groups:
Study Type: Distribution of CA 125 II assay values in various patient groups.
Sample Size: 615 individual specimens.

Ovarian Cancer Serial Specimens / Association between Change in Marker Value and Change in Disease State:
Study Type: Analysis of serial CA 125 values in ovarian cancer patients and association with disease progression.
Sample Size: 63 patients, with a total of 306 evaluable observations.
Key Results:

Total Concordance (C): 68.3%
Positive Concordance (C₁): 76.6% (calculated as 85/111 * 100)
Negatives Concertance (C-): 61.4% (calculated as 81/132 * 100)

Per Patient Analysis:
Study Type: Per-patient concordance analysis for disease state and CA 125 changes.
Sample Size: 63 patients.
Key Results:

C+: 97.9% (95% CI: 88.7%, 99.9%)
C-: 37.5% (95% CI: 15.3%, 64.5%)
C: 82.5% (95% CI: 70.9%, 91.0%)

Key Metrics

CA 125 II Assay Reproducibility:
Total precision %CV

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.

Summary

0

MOV 19 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: 10 40 731 .

Submitter Information

| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Kimberly Peterson, (610) 240-3828 |
| Summary preparation date: | September 30, 2004 |

Name of Device

Trade/Proprietary Name:	ARCHITECT® CA 125 II™ Assay
Common/Usual Name:	CA 125 Assay
Classification Name:	Test, Epithelial Ovarian Tumor-associated Antigen (CA125)

Predicate Device

AxSYM® CA 125™ Assay

Device Description

The ARCHITECT CA 125 II assay is a two-step immunoassay to determine the presence of OC125 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 of the ARCHITECT CA 125 II assay, sample and OC125 coated paramagnetic microparticles are combined. CA 125 reactive determinants present in the sample bind to the OC125 coated microparticles. After washing, M11 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

1

units (RLUs). A direct relationship exists between the amount of CA 125 reactive determinants in the sample and the RLUs detected by the ARCHITECT i *optical system.

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 II reagent package insert for additional information.

Statement of Substantial Equivalence

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.

ARCHITECT CA 125 II Assay kit is substantially equivalent to Abbott Laboratories AxSYM CA 125 assay. Both of the devices are IVD products and are indicated for the quantitative determination of CA 125 assay values (CA 125 reactive determinants) and as aids in monitoring response to therapy for patients with epithelial ovarian cancer.

A comparison of the features of the ARCHITECT CA 125 II Assay device and the AxSYM CA 125 Assay follows.

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| ARCHITECT CA 125 II Assay
(Proposed Device) AxSYM® CA 125™ Assay
(Predicate Device)
K964020 |
----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| In vitro diagnostic | In vitro diagnostic |
| Class II, LTK |
| Chemiluminscent Microparticle
| Microparticle Enzyme
|
| Clinical and Hospitals laboratories
used as an aid in
cancer. | Clinical and Hospitals laboratories
| Human serum or plasma (EDTA,
| Human Serum |
Phlebotomy Techniques | Routine Phlebotomy Techniques |
| OC 125 mouse monoclonal | Anti-CA 125 sheep polyclonal |
| M11 mouse monoclonal | OC 125 mouse monoclonal |
| 6 levels (0 - 1000 U/mL) | 6 levels (0 - 600 U/mL) or 2 levels
|
| 3 levels (Low = 40 U/mL, Medium
| 3 levels (Low = 30 U/mL, Medium
|
| Standard Curve | Standard Curve |

Summary of Performance characteristics

Reproducibility:

Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Three defibrinated plasma pasel members (1, 2, and 3) were tested, using two lots of reagents, in replicates of two, at two separate times per day, for 20 days on 2 separate instruments. Each reagent lot used a single calibration curve

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The total precision was determined by calculating the standard throughout the study. 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 10%.

Comparison Study

A total of 280 serum specimens (120 of these serum samples were from Ovarian cancer Patients) were tested using the ARCHITECT CA 125 Il assay and the AxSYM CA 125 assay. Passing-Bablok linear regression analysis was performed on all specimens (4.5 - 4085.9 U/mL for the ARCHITECT CA 125 II assay and 2.7 - 3436.1 U/mL for the AxSYM CA 125 assay).

Passing-Bablok linear regression analysis comparing the ARCHITECT CA 125 II assay to the AxSYM CA 125 assay yielded a correlation coefficient of 0.985, a slope of 1.06 (99% confidence interval of 1.03, 1.11), and Y-axis intercept of 4.0 U/mL (99% confidence interval of 2.0, 4.9).

Reference Ranges:

Apparently Healthy Population:

The distribution of CA 125 II assay values determined in 196 normal individual specimens is shown in the table below:

Distribution of ARCHITECT CA 125 II Assay Values
	Percent (%)
	Number of
Subjects	0-35 U/mL	35.1-65 U/mL	65.1-100 U/mL	>100 U/mL
APPARENTLY
HEALTHY
Females (Pre-
Menopausal)	99	89.9	6.1	4.0	0.0
Females (Post-
Menopausal)	97	99.0	1.0	0.0	0.0

In this study, 94.4% of the healthy female subjects had CA 125 II assay values at or below 35.0 U/mL. (mean = 16.4, SD = 13.0)

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Patient Groups:

The distribution of CA 125 II assay values determined in 615 pf various patient groups individual specimens is shown in the table below:

Distribution of ARCHITECT CA 125 II Assay Values
Number of Subjects	0-35 U/mL	35.1-65 U/mL	65.1-100 U/mL	>100 U/mL
MALIGNANT CONDITIONS
Breast Cancer	50	80.0	20.0	0.0	0.0
Ovarian Cancer	166	49.9	14.3	4.8	32.8
Colorectal Cancer	50	84.0	4.0	10.0	2.0
Endometrial Cancer	25	96.0	4.0	0.0	0.0
Lung Cancer	50	60.0	18.0	10.0	12.0
NON MALIGNANT CONDITIONS
Ovarian Disease	100	90.0	9.0	1.0	0.0
Urogenital Disease	49	83.7	14.3	2.0	0.0
Hypertension/CHD	100	88.0	11.0	0.0	1.0
Benign Endometrial	25	84.0	8.0	4.0	4.0

Ovarian Cancer Serial Specimens

This analysis is based on 63 patients. There were a total of 306 evaluable observations. The average number of observations per patient is 4.9.

The average age of the subjects at time of diagnosis was 56 years (Exact 95% Cl: 52.0 years to 59.4 years). Ninety-three percent of the cohort was post-menopausal at time of diagnosis. Staging was available from the chart for 60 of the 63 women. The majority of the women were stage III (67.7%) while 6.7% and 21.7% were stage I and IV respectively.

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 CA 125 value and progression of the disease from one observation to the next. A positive change in CA 125 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 10.75%. The following Table (entitled "Distribution of W by V") presents the results for the 243 observation pairs in this study.

Three estimates of Concordance are given for the following Table.

$$\text{Total Conocordance:} \quad C = \frac{85 + 81}{243} \times 100 = 68.3%$$

85 Positive Concordance: $C$₁ = ×100 = 76.6% 11

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$$\text{Negatives} \text{ \textbf{Concentance}: } C_{-} = \frac{81}{132} \times 100 = 61.4%$$

Distribution of W by V

Change in Disease State (W)
Change in CA 125
(V)	Progression	No Progression	Total
≥ 10.75%	85	51	136