(49 days)
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.
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.
Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting study:
The document describes the ARCHITECT CA 125 II Assay, a diagnostic device, and its 510(k) submission. It focuses on demonstrating substantial equivalence to a predicate device, the AxSYM CA 125 Assay.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/Derived from Predicate) | Reported Device Performance (ARCHITECT CA 125 II Assay) |
|---|---|---|
| Reproducibility | Total precision %CV should be acceptable for a diagnostic assay (implicitly comparable to predicate). | Total precision %CV was determined to be less than or equal to 10%. |
| Method Comparison (Correlation with Predicate) | High correlation with the predicate device (AxSYM CA 125 assay). | Correlation coefficient of 0.985. |
| Method Comparison (Slope vs. Predicate) | Slope of approximately 1.0 when compared to the predicate device. | Slope of 1.06 (99% CI: 1.03, 1.11). |
| Method Comparison (Y-axis Intercept vs. Predicate) | Y-axis intercept close to 0 when compared to the predicate device. | Y-axis intercept of 4.0 U/mL (99% CI: 2.0, 4.9). |
| Reference Range (Healthy Females Pre-Menopausal) | (Implicitly, comparable to established CA 125 levels in healthy population). | 89.9% ≤ 35 U/mL; 6.1% 35.1-65 U/mL; 4.0% 65.1-100 U/mL; 0.0% > 100 U/mL. 94.4% of healthy females had values ≤ 35.0 U/mL. |
| Reference Range (Healthy Females Post-Menopausal) | (Implicitly, comparable to established CA 125 levels in healthy population). | 99.0% ≤ 35 U/mL; 1.0% 35.1-65 U/mL; 0.0% 65.1-100 U/mL; 0.0% > 100 U/mL. |
| Association between CA 125 Change and Disease State (Total Concordance) | (Implied: Demonstrates clinical utility in monitoring response to therapy). | 68.3% Total Concordance based on observation pairs. |
| Association between CA 125 Change and Disease State (Positive Concordance) | (Implied: Demonstrates clinical utility in monitoring response to therapy). | 76.6% Positive Concordance based on observation pairs. |
| Association between CA 125 Change and Disease State (Negative Concordance) | (Implied: Demonstrates clinical utility in monitoring response to therapy). | 61.4% Negative Concordance based on observation pairs. |
| Per-Patient Concordance (Positive) | (Implied: Demonstrates clinical utility in monitoring response to therapy on a per-patient basis). | 97.9% (95% CI: 88.7% - 99.9%) |
| Per-Patient Concordance (Negative) | (Implied: Demonstrates clinical utility in monitoring response to therapy on a per-patient basis). | 37.5% (95% CI: 15.3% - 64.5%) |
| Per-Patient Concordance (Total) | (Implied: Demonstrates clinical utility in monitoring response to therapy on a per-patient basis). | 82.5% (95% CI: 70.9% - 91.0%) |
Note on Acceptance Criteria: For a 510(k) submission seeking substantial equivalence, explicit quantitative acceptance criteria are often not stated in the summary as they would be for a PMA. Instead, the performance demonstrated is compared directly to the predicate device's known performance or to generally accepted diagnostic assay performance characteristics (e.g., precision limits, strong correlation). The document's structure implies that the demonstrated performance is considered sufficient to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Reproducibility (Precision): Three defibrinated plasma panel members were tested. The exact number of samples from these panel members is not specified, but it involved replicates of two, two separate times per day, for 20 days on 2 separate instruments (total of 3 x 2 x 2 x 20 x 2 = 480 discrete measurements).
- Data Provenance: Not explicitly stated, but likely laboratory-generated samples for method validation.
- Comparison Study: 280 serum specimens (120 of these from Ovarian cancer Patients).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) for a diagnostic assay, it would likely be retrospective anonymized or de-identified clinical samples.
- Reference Ranges (Apparently Healthy Population): 196 normal individual specimens (99 pre-menopausal females, 97 post-menopausal females).
- Data Provenance: Not explicitly stated.
- Reference Ranges (Patient Groups): 615 individual specimens from various patient groups (Breast Cancer: 50, Ovarian Cancer: 166, Colorectal Cancer: 50, Endometrial Cancer: 25, Lung Cancer: 50, Ovarian Disease: 100, Urogenital Disease: 49, Hypertension/CHD: 100, Benign Endometrial: 25).
- Data Provenance: Not explicitly stated.
- Ovarian Cancer Serial Specimens (Association between Change in Marker Value and Change in Disease State): 63 patients, resulting in 306 evaluable observation pairs.
- Data Provenance: Not explicitly stated, but implies clinical data from patients undergoing therapy for ovarian cancer. It is stated that staging information was available for 60 of the 63 women.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is a diagnostic assay measuring a biomarker (CA 125). The ground truth for this type of device is typically the actual concentration of the analyte, or the clinical status of the patient as determined by various clinical methods (e.g., physician diagnosis, pathology, imaging, follow-up over time).
- No "experts" in the sense of human readers/interpreters establishing ground truth for the assay values directly are mentioned. The CA 125 values themselves are the output of the device.
- For the "Association between Change in Marker Value and Change in Disease State" section, disease progression/no progression (W) would be the clinical ground truth. The document does not specify the number of experts or their qualifications used to determine this clinical ground truth for the 63 ovarian cancer patients. It refers to "Staging was available from the chart," suggesting that standard clinical records and physician determinations served as the basis for the disease state.
4. Adjudication Method for the Test Set
- No adjudication method is described in the conventional sense (e.g., 2+1, 3+1 for imaging studies). This is expected for an automated laboratory diagnostic assay where the output is a quantitative value, not subject to human interpretation in the same way an image would be.
- For the clinical disease state (W) used in the serial specimen analysis, the method for determining "Progression" or "No Progression" is not detailed, so no adjudication method is provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study compares the performance of human readers, with and without AI assistance, typically for interpreting medical images. This document describes an automated in-vitro diagnostic (IVD) assay, which does not involve human readers interpreting AI output. The comparison is between the new assay and a predicate assay, and clinical utility is assessed by correlating assay changes with patient disease progression.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the primary performance evaluation described is a standalone performance of the algorithm (the ARCHITECT CA 125 II Assay). This device is an automated immunoassay system that provides a quantitative CA 125 value without human subjective interpretation. All presented data (precision, method comparison, reference ranges, and association with disease state) represent the performance of the device itself.
7. The Type of Ground Truth Used
- For the quantitative CA 125 values: The ground truth is considered to be the true concentration of CA 125 reactive determinants in the sample. This is implicitly confirmed by the comparison to a predicate device (which aims to measure the same analyte) and by the internal precision studies.
- For the "Association between Change in Marker Value and Change in Disease State": The ground truth is the clinical disease state or progression of ovarian cancer based on clinical methods and chart review. This is not strictly "expert consensus pathology" or "outcomes data" but rather a clinical determination of disease progression over time.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" for an algorithm. This is an immunoassay, not a machine learning algorithm in the typical sense that requires a training phase. While the assay's reagents and calibration parameters would have been developed and optimized, the specific sample sizes used in that developmental phase are not provided in this 510(k) summary focused on validation.
- The "calibration curve" mentioned in the reproducibility section suggests that a set of calibrators is used to establish the standard curve for quantitative measurement, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
- As a traditional immunoassay, there isn't a "training set" in the AI sense.
- For calibration, the ground truth for the calibrators would be established by careful preparation of known concentrations of the CA 125 antigen, typically through gravimetric or volumetric methods, and confirmation by reference methods. The document states "6 levels (0 - 1000 U/mL)" for standards, implying these are known concentrations used to create the standard curve.
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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 ParkwayMalvern, 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
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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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| Abbott LaboratoriesARCHITECT CA 125 II Assay(Proposed Device) | Abbott LaboratoriesAxSYM® CA 125™ Assay(Predicate Device)K964020 | |
|---|---|---|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification andProduct Code | Class II, LTK | Class II, LTK |
| Principle of Operation | Chemiluminscent MicroparticleImmunoassay (CMIA) | Microparticle EnzymeImmunoassay (MEIA) |
| Product UsageIntended Use | Clinical and Hospitals laboratoriesThe ARCHITECT® CA 125 II™assay is a ChemiluminescentMicroparticle Immunoassay(CMIA) for the quantitativedetermination of CA 125 reactivedeterminants in human serum andplasma on the ARCHITECT iSystem. The ARCHITECT CA 125II assay is to be used as an aid inmonitoring response to therapy forpatients with epithelial ovariancancer. Serial testing for patientCA 125 II assay values should beused in conjunction with otherclinical methods used formonitoring ovarian cancer. | Clinical and Hospitals laboratoriesThe AxSYM CA 125 assay is amicroparticle enzymeimmunoassay (MEIA) for thequantitative measurement of CA125 assay values in human serum.The AxSYM CA 125 assay is to beused as an aid in monitoringresponse to therapy for patientswith epithelial ovarian cancer.Serial testing for patient CA 125assay values should be used inconjunction with other clinicalmethods for monitoring ovariancancer. |
| Type of Specimen | Human serum or plasma (EDTA,Lithium Heparin, Sodium Heparin) | Human Serum |
| Specimen CollectionMethod | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Capture Antibody | OC 125 mouse monoclonal | Anti-CA 125 sheep polyclonal |
| Conjugate Antibody | M11 mouse monoclonal | OC 125 mouse monoclonal |
| Standards | 6 levels (0 - 1000 U/mL) | 6 levels (0 - 600 U/mL) or 2 levels(Master Cals: 0 and 50 U/mL) |
| Controls | 3 levels (Low = 40 U/mL, Medium= 300, High = 650 U/mL) | 3 levels (Low = 30 U/mL, Medium= 80 U/mL, High = 200 U/mL) |
| Interpretation of Results | 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 ofSubjects | 0-35 U/mL | 35.1-65 U/mL | 65.1-100 U/mL | >100 U/mL | |
| APPARENTLYHEALTHY | |||||
| 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 |
| < 10.75% | 26 | 81 | 107 |
| Total | 111 | 132 | 243 |
Per Patient Analysis
The table below (entitled " Per Patient Distribution) demonstrates this distribution for the 63 patients in this study.
| Change in Disease State (W) | |||
|---|---|---|---|
| Change in CA 125 (V) | Progression | No Progression | Total |
| ≥ 10.75% | 46 | 10 | 56 |
| < 10.75% | 1 | 6 | 7 |
| Total | 47 | 16 | 63 |
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.
| Positive, Negative and Total ConcordanceWith 95% Confidence Intervals | |||
|---|---|---|---|
| Statistic | Estimate | Lower Bound | Upper Bound |
| C+ | 97.9% | 88.7% | 99.9% |
| C. | 37.5% | 15.3% | 64.5% |
| C | 82.5% | 70.9% | 91.0% |
Estimate of Per-Patient r
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 9 2004
Ms. Kimberly Peterson Director, Clinical and Regulatory Affairs Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy Malvern, PA 19355-1307
Re: K042731
Trade/Device Name: ARCHITECT CA 125 II Reagent Kit ARCHITECT CA 125 II Calibrator Kit ARCHITECT CA 125 II Control Kit Regulation Number: 21 CFR 866.6010 Regulation Name: Carcinoembryonic Antigen (CEA) Immunological Test System Regulatory Class: Class II Product Code: LTK, JIT, JJX Dated: September 30, 2004 Received: October 4, 2004
Dear Ms Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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 Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 – Ms. Kimberly Peterson
labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3084. 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 Division 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. Bretton, Jr., M.D., Ph.D.
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K042731 510(k) Number (if known):
Device Name: ARCHITECT® CA 125 II™ Assay
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.
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)
Maiva M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of / Updated August 30, 2004
510(k) K042731
133
§ 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.