(115 days)
Not Found
No
The description focuses on a quantitative immunoassay for a specific antigen and does not mention any AI/ML components or algorithms.
No
The device is an in vitro diagnostic device used for measuring CA 15-3 antigen levels, aiding in the detection of recurrence and management of breast cancer, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and describes its purpose as an "aid in the detection of recurrence" and in "monitoring disease progression or response to treatment" for breast cancer patients, which clearly falls under diagnostic applications.
No
The device description explicitly states that the devices are "clinical use devices intended for use with their respective IMMULITE and IMMULITE 2000 Automated Immunoassay Analyzers" and are "two-step sequential chemiluminescent enzyme immunoassays, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase." This indicates the device includes physical reagents and is used in conjunction with hardware analyzers, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence of both descriptions explicitly states "For in vitro diagnostic use".
- Device Description: The description states that the devices are "clinical use devices intended for use with their respective IMMULITE and IMMULITE 2000 Automated Immunoassay Analyzers for the quantitative measurement of CA15-3 antigen in serum." This describes a test performed on a biological sample (serum) outside of the body, which is the definition of in vitro.
- Performance Studies: The performance studies describe testing on "specimens" and "patients," and the results are presented in terms of clinical metrics like Sensitivity, Specificity, PPV, and NPV, which are relevant to diagnostic testing.
The entire document describes a device used to perform a test on a biological sample to aid in the diagnosis and management of a medical condition (breast cancer), which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IMMULITE BR-MA and IMMULITE 2000 BR-MA are clinical use devices intended for in vitro diagnostic use with IMMULITE analyzer - for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and stage IIII disease and for monitoring response to treatment in patients with metastatic breast cancer.
Product codes (comma separated list FDA assigned to the subject device)
MOI
Device Description
IMMULITE BR-MA and IMMULITE 2000 BR-MA are clinical use devices intended for use with their respective IMMULITE and IMMULITE 2000 Automated Immunoassay Analyzers for the quantitative measurement of CA15-3 antigen in serum.
IMMULITE BR-MA and IMMULITE 2000 BR-MA are two-step sequential chemiluminescent enzyme immunoassays, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Equivalence - Performance Characteristics (Calibration upper limit, Analytical Sensitivity, Precision (within-run), Precision (total), Specificity, Linearity, Spiking Recovery, Effect of Bilirubin (unconjugated), Effect of Lipemia, Effect of Hemolysis, High Dose Hook Effect, Stability):
The IMMULITE BR-MA and IMMULITE 2000 BR-MA devices show comparable performance characteristics to the predicate device, with similar analytical sensitivity and stability. Precision values (CV ranges) and recovery percentages demonstrate consistent performance.
Performance Equivalence - Method Comparison (Breast Cancer Patients and Healthy Subjects):
- IMMULITE BR-MA vs. Kit A: 1400 specimens (healthy females, pregnant women, breast cancer patients). Qualitative agreement 87.8% (95% CI for positive agreement: 92.0% - 96.9%, negative agreement: 83.3% - 87.5%). Linear regression (n=1307): IMMULITE BR-MA = 1.08 (Kit A) + 8.34, r = 0.79.
- IMMULITE BR-MA vs. Kit B: 181 specimens. Qualitative agreement 90.1% (95% CI for positive agreement: 85.4% - 98.4%, negative agreement: 80.3% - 93.1%). Linear regression (n=157): IMMULITE BR-MA = 0.86 (Kit B) + 10.4 U/mL, r = 0.95.
- IMMULITE 2000 BR-MA vs. Kit A: 500 specimens. Qualitative agreement 86.8% (95% CI for positive agreement: 88.7% - 97.4%, negative agreement: 80.3% - 87.8%). Linear regression (n=447): IMMULITE 2000 BR-MA = 1.04 (Kit A) + 7.66, r = 0.85.
- IMMULITE 2000 BR-MA vs. IMMULITE BR-MA: 466 specimens. Linear regression: IMMULITE 2000 BR-MA = 1.02 (IMMULITE BR-MA) + 0.90, r = 0.99.
Clinical Performance:
- IMMULITE BR-MA (recurrence): 99 breast cancer patients. 81% agreement with clinical status. For 294 specimens: Sensitivity 72% (95% CI: 59-83%), Specificity 84% (95% CI: 79-88%).
- IMMULITE BR-MA (response to treatment): 80 breast cancer patients. 66% agreement with clinical status. For 282 specimens: Sensitivity 74% (95% CI: 68-79%), Specificity 57% (95% CI: 35-77%).
- IMMULITE 2000 BR-MA (recurrence): 35 breast cancer patients. 80% agreement with clinical status. For 121 specimens: Sensitivity 75% (95% CI: 58-88%), Specificity 76% (95% CI: 66-85%).
- IMMULITE 2000 BR-MA (response to treatment): 15 breast cancer patients. 80% agreement with clinical status. For 67 specimens: Sensitivity 85% (95% CI: 74-92%), Specificity 50% (95% CI: 1-99%).
Longitudinal monitoring profiles for both IMMULITE BR-MA and IMMULITE 2000 BR-MA showed correlation with changes in disease status.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
IMMULITE BR-MA for recurrence:
Sensitivity (95% CI): 72% (59-83%)
Specificity (95% CI): 84% (79-88%)
PPV* (95% CI): 51% (40-63%)
NPV* (95% CI): 93% (88-96%)
IMMULITE BR-MA for response to treatment:
Sensitivity (95% CI): 74% (68-79%)
Specificity (95% CI): 57% (35-77%)
PPV* (95% CI): 95% (91-98%)
NPV* (95% CI): 16% (9-26%)
IMMULITE 2000 BR-MA for recurrence:
Sensitivity (95% CI): 75% (58-88%)
Specificity (95% CI): 76% (66-85%)
PPV* (95% CI): 57% (42-72%)
NPV* (95% CI): 88% (78-94%)
IMMULITE 2000 BR-MA for response to treatment:
Sensitivity (95% CI): 85% (74-92%)
Specificity (95% CI): 50% (1-99%)
PPV* (95% CI): 98% (91-100%)
NPV* (95% CI): 9% (0-41%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510 (k) Summary of Safety and Effectiveness IMMULITE® and IMMULITE® 2000 BR-MA
This summary of 510(k) safety and effectiveness information is being submitted in Inis sammal y of broke visements of SMDA 1990 and 21 CFR Part 807.92.
| Name:
Address: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045 | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Telephone Number: | (310) 645-8200 | |
| Contact Person | Edward M. Levine, Ph.D. | |
| Date of Preparation: | March 22, 2002 | |
| Catalog Number: | LKBR1, LKBR5 (100, 500 tests)
L2KBR2 (200 tests) | |
| Device Name
Trade: | IMMULITE® BR-MA and
IMMULITE® 2000 BR-MA | |
| Common: | Reagent system for the determination of CA15-3 antigen in
serum. | |
| Classification: | MOI, Class II device | |
| Manufacturer of
IMMULITE BR-MA: | Euro/DPC Limited
Glyn Rhonwy
Llanberis, Gwynedd LL55 4EL
United Kingdom
(Manufactured under a Quality System-
ISO9002/ISO13488/EN46002) | |
| Sole U. S. Importer of
IMMULITE BR-MA: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597 | |
| Manufacturer of
IMMULITE 2000 BR-MA: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
(Manufactured under a Quality System-
ISO9001/21CFR,Part 820/EN46001) | |
1
1
Establishment Registration #: Euro/DPC - Not applicable DPC Registration number is 2017183
Substantially Equivalent Predicate Devices:
Baver Immuno 17M CA 15-3TM (K964703) Chiron ACS 180 BR (CA27.29)
Description of Device:
IMMULITE BR-MA and IMMULITE 2000 BR-MA are clinical use devices intended for use with their respective IMMULITE and IMMULITE 2000 Automated Immunoassay Analyzers for the quantitative measurement of CA15-3 antigen in serum.
Intended Use of the Device:
IMMULITE BR-MA and IMMULITE 2000 BR-MA are clinical use devices intended for in vitro diagnostic use with IMMULITE analyzer - for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and stage IIII disease and for monitoring response to treatment in patients with metastatic breast cancer.
Summary and Explanation of the Test:
CA 15-3 is a high molecular weight (300 to 450 kDa) polymorphic epithelial mucin. The heterogeneous breast cancer associated mucins consist of a repeated polypeptide core sequence and an outer shell of carbohydrate. Serum CA 15-3 values increase with clinical stage of breast cancer, the highest values occurring in metastatic disease. Serial determinations of CA 15-3 are most useful as an indicator of response to therapy. The measurement of CA 15-3 antigen is more sensitive and specific than the determination of carcinoembryonic antigen (CEA), having a lower percentage positivity with benign breast lesions, liver cirrhosis and other carcinomas -- 99.9% of serum donated by healthy volunteers contained less than 40 U/mL of CA 15-3 is not elevated during pregnancy. The percentage of raised values found in breast cancer can be as high as 98%, but this depends primarily on the tumor stage of the patient population studied. Elevated levels have also been found in patients with lung cancer (63%) and ovarian cancer (80%).
IMMULITE BR-MA and IMMULITE 2000 BR-MA are two-step sequential chemiluminescent enzyme immunoassays, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.
2
Performance Equivalence - Technology Comparison:
IMMULITE BR-MA is a chemiluminescent enzyme immunoassay and Immuno 1 CA 15-3 is a magnetic separation assay. The technology in DPC's IMMULITE BR-MA and IMMULITE 2000 BR-MA is identical to technology used in previously cleared and commercially marketed IMMULITE and IMMULITE 2000 products.
IMMULITE BR-MA is a two-step sequential chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase. The patient sample and a ligand-labeled anti-CA15-3 monoclonal antibody are simultaneously introduced into the Test Unit, containing immobilized anti-ligand, and incubated for approximately 30 minutes at 37℃ with intermittent agitation. During this time, CA 15-3 antigen in the sample binds to the ligand-labeled monoclonal antibody, which, in turn, binds to the anti-ligand on the solid phase. Unbound serum is then removed by centrifugal wash. An alkaline phosphataselabeled anti-CA 15-3 monoclonal antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for a further 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CA 15-3 in the sample.
IMMULITE 2000 BR-MA is a two-step sequential chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase. The patient sample and a ligand-labeled anti-CA15-3 monoclonal antibody are simultaneously introduced into the Reaction Tube, containing immobilized anti-ligand, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, CA 15-3 antigen in the sample binds to the ligand-labeled monoclonal antibody, which, in turn, binds to the anti-ligand on the solid phase. Unbound serum is then removed by centrifugal wash. An alkaline phosphataselabeled anti-CA 15-3 monoclonal antibody is introduced, and the Reaction Tube is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for a further 5 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CA 15-3 in the sample.
3
The Bayer Immuno 1 CA 15-3 Assay uses a sandwich immunoassay format. 115D8 Antibody Conjugate (R1) and mIMP® (monoclonal ImmunoMagnetic Particle) Reagent are reacted with patient sample (or calibrator containing CA 15-3 reactive determinants) and incubated on the system at 37°C. The DF3 Enzyme Conjugate (R2) is then added. A second incubation occurs during which the antibody complex is bound. After incubation, the complex is washed and the pNPP (para-nitrophenyl phosphate) substrate is added. The alkaline phosphatase (ALP) in the antibody conjugate reacts with the pNPP to form para-nitrophenoxide and phosphate. Increasing absorbance, due to the formation of paranitrophenoxide, is monitored at 405 nm and 450 nm.
A sample have no CA 15-3 Assay value will have the minimum label bound, while a sample having a high CA 15-3 Assay value will have maximum label bound. Thus, the dose response curve is proportional to the DF3 reactive determinants in the sample.
4
Performance Equivalence - Performance Characteristics:
| Characteristics | IMMULITE BR-
MA | IMMULITE 2000
BR-MA | Immuno 1
CA 15-3 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration upper limit | 300 U/mL | 300 U/mL | 200 U/mL |
| Analytical Sensitivity | 0.2 U/mL | 0.2 U/mL | 0.2 U/mL |
| Precision (within-run) | CV range: 5.5-8.1% | CV range: 3.7-4.9% | CV range: 1.3-3.4% |
| Precision (total) | CV range: 7.4-8.8% | CV range: 4.5-6.5% | CV range: 3.0-4.0% |
| Specificity | No significant cross-
reactivity with the
following compounds
5-Fluorouracil, AFP,
CA 125, CA 19-9,
CEA, Cisplatin,
Cyclophosphamide,
Doxorubicin,
hydrochloride,
Mitomycin C,
Vincristine | No significant cross-
reactivity with the
following compounds
5-Fluorouracil, AFP,
CA 125, CA 19-9,
CEA, Cisplatin,
Cyclophosphamide,
Doxorubicin,
hydrochloride,
Mitomycin C,
Vincristine | Data not available |
| Linearity | %Observed/Expected
range: 95-105% | %Observed/Expected
range: 93-104% | Data not available |
| Spiking Recovery | %Observed/Expected
range:
89-114% | %Observed/Expected
range:
92-108% | Data not available |
| Effect of Bilirubin
(unconjugated) | No significant effect | No significant effect | No clinically significant
effect |
| Effect of Lipemia | No significant effect | No significant effect | No clinically significant
effect |
| Effect of Hemolysis | No significant effect | No significant effect | No clinically significant
effect |
| High Dose Hook Effect | No effect up to 80,000
U/mL | No effect up to 80,000
U/mL | Data not available |
| Stability | Unopened kits kept
at specified
conditions are stable
for 2 months. Kits
are stable for one
year when kept in
long-term storage | Unopened kits kept at
specified conditions
are stable for 2
months. Kits are
stable for one year
when kept in long-
term storage
conditions. | Unopened kits kept at
specified conditions are
stable through the last
day of the month on the
product label. Long-
term stability data not
available. |
The information in the table below provides the performance characteristics of IMMULITE and IMMULITE 2000 BR-MA and Immuno 1 CA 15-3.
5
Performance Equivalence - Method Comparison (Breast Cancer Patients and Healthy Subjects):
IMMULITE BR-MA
The IMMULITE BR-MA assay was compared to Kit A, a commercially available immunoassay that also measured CA 15-3, at two clinical sites in the northeastern and southern United States. A total of 1400 specimens from apparently healthy female subjects and pregnant women, and female patients with breast cancer, malignant and nonmalignant diseases, were evaluated at the two clinical sites. Using the 95th percentile of the normal reference ranges of the two assays (38 U/mL for IMMULITE BR-MA and 34.8 U/mL for Kit A), a qualitative comparison of the IMMULITE BR-MA and Kit A yielded the following results.
| IMMULITE BR-MA | | Positive
Agreement | Negative
Agreement |
|----------------|----------------------|-----------------------|-----------------------|
| Kit A | > 38 U/mL ≤ 38 U/mL | | |
| > 34.8 U/mL | 334 18 | 94.9% | 85.2% |
| ≤ 34.8 U/mL | 153 895 | | |
Agreement: 87.8%
95% Confidence Limits for positive agreement and negative agreement, respectively: 92.0% - 96.9% and 83.3% - 87.5%.
The CA 15-3 measurements of 1307 specimens that fell within the working range of both assays (300 U/mL for IMMULITE BR-MA and 200 U/mL for Kit A) were compared in a linear regression:
IMMULITE BR-MA = 1.08 (Kit A) + 8.34 r = 0.79
95% Confidence Intervals: Slope: 1.04, 1.13 Intercept: 6.53, 10.2
Means:
39.4 U/mL (IMMULITE BR-MA) 28.7 U/mL (Kit A)
In the clinical study conducted in the southern United States, measurements of CA 15-3 by IMMULITE BR-MA were compared to measurements by Kit B, a commercially available chemiluminescence assay for CA 27-29 on 181 specimens using the respective normal range upper limits of the two assays as the cutoff (38 U/mL for IMMULITE BR-MA and 38.6 U/mL for Kit B).
| | IMMULITE BR-MA | | Positive
Agreement | Negative
Agreement |
|-------------|----------------|-----------|-----------------------|-----------------------|
| Kit B | > 38 U/mL | ≤ 38 U/mL | | |
| > 38.6 U/mL | 63 | 4 | 94.0% | 87.7% |
| ≤ 38.6 U/mL | 14 | 100 | | |
90.1% Agreement:
95% Confidence Limit for positive agreement: 85.4% - 98.4% 95% Confidence Limit for negative agreement: 80.3% - 93.1%
6
A subset of the specimens (n=157) within the working ranges of both assays were compared in a linear regression:
IMMULITE BR-MA = 0.86 (Kit B) + 10.4 U/mL r = 0.95 95% Confidence Intervals: 0.82, 0.91 Slope: Slope: Intercept: 7.61. 13.2
Means:
49.1 U/mL (IMMULITE BR-MA) 44.8 U/mL (Kit B)
IMMULITE 2000 BR-MA
The IMMULITE 2000 BR-MA assay was compared to Kit A, a commercially available immunoassay that also measured CA 15-3, at one clinical site in the northeastern United States. A total of 500 specimens from apparently healthy female subjects and pregnant women, and female patients with breast cancer, malignant and nonmalignant dieseases, were evaluated at this clinical site. Using the 95th percentile of the normal reference were cranated at this entired. Cor IMMULITE 2000 BR-MA and 34.8 U/mL for Kit A), a qualitative comparison of the IMMULITE BR-MA and Kit A yielded the following results.
| IMMULITE 2000 BR-MA | | | Positive
Agreement | Negative
Agreement |
|---------------------|-----------|-----------|-----------------------|-----------------------|
| Kit A | > 38 U/mL | ≤ 38 U/mL | | |
| > 34.8 U/mL | 128 | 8 | 94.1% | 84.1% |
| ≤ 34.8 U/mL | 58 | 306 | | |
Agreement: 86.8%
95% Confidence Limits for positive agreement and negative agreement, respectively: 88.7% - 97.4% and 80.3% - 87.8%.
The CA 15-3 measurements of 447 specimens that fell within the working range of both assays (300 U/mL for IMMULITE 2000 BR-MA and 200 U/mL for Kit A) were compared in a linear regression:
IMMULITE 2000 BR-MA = 1.04 (Kit A) + 7.66 r = 0.85
95% Confidence Intervals: Slope: 0.98. 1.10 Intercept: 5.37, 9.95 Means: 37.2 U/mL (IMMULITE 2000 BR-MA) 28.4 U/mL (Kit A)
7
In the same study, IMMULITE 2000 BR-MA was compared to IMMULITE BR-MA in a linear regression for 466 specimens that fell within the working range of both assays:
IMMULITE 2000 BR-MA = 1.02 (IMMULITE BR-MA) + 0.90 r = 0.99
95% Confidence Intervals: Slope: 1.01, 1.04 Intercept: 0.04, 1.76
Means:
42.8 U/mL (IMMULITE BR-MA) 44.7 U/mL (IMMULITE 2000 BR-MA)
Clinical Performance:
In two clinical studies conducted in the northeastern and southern United States, serial samples from 99 breast cancer patients followed for recurrence and 80 patients followed for response to treatment were tested by IMMULITE BR-MA and compared with the clinical history of these patients.
An analysis of these cases considered IMMULITE /IMMULITE 2000 BR-MA as consistent, inconsistent, or equivocal with clinical status if over half, less than half, or exactly half of the specimens tested for a case agreed with the clinical status.
IMMULITE BR-MA measurements accurately reflected the changes in the clinical status in 80 of the 99 (81%) patients followed for recurrence. Of the remainder, 13 (13%) did not parallel the clinical status, and 6 of the 99 (6%) were equivocal as to whether CA 15-3 reflected the clinical status.
For all 294 specimens from patients followed for recurrence, the IMMULITE BR-MA measurements were compared with the clinical status of the breast cancer patients:
| Clinical
Status | IMMULITE
38 U/mL | 38 U/mL | 38 U/mL | 38 U/mL | Trade/Device Name: IMMULITE® BR-MA and IMMULITE® 2000 BR-MA Regulation Number: 21 CFR § 866.6010 Regulation Name: Tumor Associated Antigen Immunological Test System Regulatory Class: II Product Code: MOI Dated: March 4, 2002 Received: March 5, 2002
Dear Dr. Levine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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.
13
Page 2
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
14
510(k) Number (if known): K013984 Device Name: IMMULITE® BR-MA IMMULITE® 2000 BR-MA
Indications For Use:
IMMULITE BR-MA
For in vitro diagnostic use with IMMULITE analyzer – for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and Stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.
IMMULITE 2000 BR-MA
For in vitro diagnostic use with IMMULITE 2000 analyzer – for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and Stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.
ed
Division Sign-Off Division of Clinical Laboratory Devices
510(k) Number Ko 13984
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
/
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)