(61 days)
Not Found
No
The description details a standard immunoassay using electrochemiluminescence detection and a calibration curve for results, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an immunoassay for the in vitro determination of CA 125 reactive determinants, used as an aid in the detection and management of ovarian cancer. It is a diagnostic device, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma" and "to aid in the management of cancer patients" through serial measurement, which are diagnostic purposes.
No
The device description clearly outlines a complex immunoassay process involving reagents, microparticles, electrochemiluminescence detection, and a physical instrument (implied by "measuring cell," "electrode," and "photomultiplier"). This indicates a hardware-dependent system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro determination of OC 125 reactive determinants." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory test performed on a sample (serum and plasma) using reagents and an instrument to measure a specific analyte (CA 125 II). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The "Summary of Performance Studies" describes studies like precision, linearity, and method comparison, which are standard performance evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K972162) indicates that this device is being compared to a previously cleared IVD device, further confirming its classification.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys® CA 125II assay is further indicated for serial measurement of CA 125II to aid in the management of cancer patients.
Product codes (comma separated list FDA assigned to the subject device)
LTK
Device Description
The Elecsys® CA 125 II™ employs a sandwich test principle with monoclonal antibodies directed against CA 125 II and with streptavidin microparticles and electrochemiluminescence detection.
Total duration of assay: 18 minutes.
- 1st Incubation: 40 ul of sample, a biotinylated monoclonal CA 125 II-specific antibody and a monoclonal CA 125 II-specific antibody labeled with a ruthenium complex react to form a sandwich complex.
- 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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)
Precision (Elecsys 1010):
- Control 1: N=60, Within-Run %CV=0.98, Total %CV=2.26 (Mean=41.8 U/mL)
- Control 2: N=60, Within-Run %CV=1.15, Total %CV=2.65 (Mean=129.2 U/mL)
- Pool 1: N=60, Within-Run %CV=1.15, Total %CV=3.13 (Mean=44.1 U/mL)
- Pool 2: N=60, Within-Run %CV=0.84, Total %CV=2.82 (Mean=142.9 ng/mL)
- Pool 3: N=60, Within-Run %CV=0.76, Total %CV=2.13 (Mean=591.4 ng/mL)
Lower Detection Limit (Elecsys 1010): 0.222 U/mL
Linearity (Elecsys 1010): 0.6 - 5,000 U/ml
Method Comparison (Elecsys 1010 vs Elecsys 2010):
- Least Squares: y = 0.9614x - 2.15, r = 0.997, SEE = 47.22, N = 93
- Passing Bablock: y = 0.9745x + 3.15, r = 0.997, SEE = 16.76, N = 93
Hook Effect (Elecsys 1010): No Hook Effect up to 24,000 U/ml CA 125
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Elecsys 2010 (K972162)
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
Boehringer Mannheim Corporation Elecsys® CA 125II on Elecsys® 1010 510(k) January, 1998
MAR 25 1998
510(k) Summary
Elecsys® CA 125II on Elecsys 1010
Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, CA 94566-0900 (510) 730-8415 Contact Person: Jody J. Savage Date Prepared: January 22, 1998 |
|---|---|
| 2. Device name | Proprietary name: Elecsys® CA 125 II ™ Common name: Epithelial Ovarian Tumor Associated Antigen Classification name: Tumor Associated Antigen Immunological Test System |
We claim substantial equivalence to the Elecsys® CA 125IITM Assay on Predicate device Elecsys 2010.
CA125 1010 510(k).doc
1
510(k) Summary, Continued
- The Elecsys® CA 125 II™ employs a sandwich test principle with Device monoclonal antibodies directed against CA 125 II and with streptavidin Description microparticles and electrochemiluminescence detection.
Total duration of assay: 18 minutes.
- · 1st Incubation: 40 ul of sample, a biotinylated monoclonal CA 125 IIspecific antibody and a monoclonal CA 125 II-specific antibody labeled with a ruthenium complex react to form a sandwich complex.
- 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
·The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
·Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
Immunoassay for the in vitro determination of OC 125 reactive determinants. 5. Intended use These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys CA 125II assay is further indicated for serial measurement of CA 125II to aid in the management of cancer patients.
2
510(k) Summary, Continued
The Boehringer Mannheim Elecsys® CA 125II Assay is under review for use on the Elecsys 2010 immunoassay analyzer (K972162). The application of the Comparison to Elecsys® CA 125II Assay on the Elecsys 1010 immunoassay analyzer is predicate device substantially equivalent to the same assay (Elecsys CA 125II Assay) on the Elecsys 2010. The following table compares the Elecsys® CA 125II on the Elecsys 1010 with the predicate device, Elecsys® CA 125II on the Elecsys 2010. Specific data on the performance of this test for both the Elecsys 1010 and 2010 have been incorporated into the draft labeling in Section 5. Labeling for the predicate device provided in Section 6 will be replaced upon the approval of this premarket approval submission with the combined Elecsys 2010 and 1010 insert (Section 5).
Similarities:
·Intended Use: Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than or equal to 35 U/ml is predictive of residual disease. The Elecsys CA 125II assay is further indicated for serial measurement of CA 125II to aid in the management of cancer patients.
· Assay range: 0.6 - 5000 U/mL
· Assay methodology: Sandwich immunoassay
·Kit (cat. no. 1776223) intended for use on the Elecsys 2010 (K972162)
·Sample and reagent volumes
·Incubation temperature and reaction times
·Package insert
·Performance specifications
·Reagents
3
510(k) Summary, Continued
Differences:
Comparison to predicate device cont.
| Feature | Elecsys 1010 | Elecsys 2010 |
|---|---|---|
| Instrument | ||
| required | Elecsys 1010 | Elecsys 2010 |
| Instrument | ||
| System | Batch | Random access |
| Reagent | ||
| Storage Temp | ||
| (C) | Ambient Temperature | 20° C |
Performance Characteristics:
| Feature | Elecsys 1010 | Elecsys 2010 | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (U/mL): | Modified NCCLS (U/mL): | ||||
| Sample | Control 1 | Control 2 | Pool 1 | TM1 | TM 2 | HS low |
| N | 60 | 60 | 60 | 60 | 60 | 60 |
| Within-Run | 41.8 | 129.2 | 44.1 | 39.03 | 121.45 | 7.83 |
| %CV | 0.98 | 1.15 | 1.15 | 1.91 | 1.41 | 3.29 |
| Total | 41.8 | 129.2 | 44.1 | 39.03 | 121.45 | 7.83 |
| %CV | 2.26 | 2.65 | 3.13 | 2.53 | 2.70 | 4.19 |
| Modified NCCLS (ng/mL): | Modified NCCLS (U/mL): | |||||
| Pool 2 | Pool 3 | HS med | HS high | |||
| N | 60 | 60 | 60 | 60 | ||
| Within-Run | 142.9 | 591.4 | 38.28 | 70.82 | ||
| %CV | 0.84 | 0.76 | 2.14 | 2.06 | ||
| Total | 142.9 | 591.4 | 38.28 | 70.82 | ||
| %CV | 2.82 | 2.13 | 3.05 | 2.48 |
Continued on next page
4
ﺟ
510(k) Summary, Continued
Performance Characteristics:
predicate device, cont.
Comparison to
| Feature | Elecsys 1010 | Elecsys 2010 |
|---|---|---|
| Lower | ||
| Detection Limit | 0.222 U/mL | 0.5 U/ml |
| Linearity | 0.6 - 5,000 U/ml | 0.6 - 5,000 U/ml |
| Method | ||
| Comparison | Vs Elecsys 2010 | vs. CENTOCOR CA 125 II |
| RIA | ||
| Least Squares: | ||
| $y=0.9614x - 2.15$ | ||
| $r=0.997$ | ||
| $SEE=47.22$ | ||
| $N=93$ | Least Squares: | |
| $N = 139$ | ||
| $y = 0.93x + 5.57$ | ||
| $r = 0.98$ | ||
| Passing Bablock | ||
| $y=0.9745x + 3.15$ | ||
| $r=0.997$ | ||
| $SEE=16.76$ | ||
| $N=93$ | Passing/Bablock | |
| $N = 139$ | ||
| $y = 0.98x + 5.08$ | ||
| $r = 0.98$ | ||
| Hook Effect | No Hook Effect up to | |
| 24,000 U/ml CA 125 | No Hook Effect up to | |
| 30,000 U/mL CA 125 |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Patricia M. Klimley Manager, Requlatory Affairs Boehringer Mannheim Corporation Laboratory Diagnostics 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
MAR 2 5 1998
Re : K980240 Trade Name: Elecsys® CA 125 II™ Requlatory Class: II Product Code: LTK Dated: January 22, 1998 Received: January 23, 1998
Dear Ms. Klimley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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
7
510(k) Number (if known): N/A
Device Name: Elecsys® CA 125Assay
Indications For Use:
Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys CA 125II is further indicated for serial measurement of CA 125II to aid in the management of cancer patients.
Deborah M. Moore
for D. Peter Mafim
(Division Sign Off)
Division Sian-Off Division of Clinical Labora 510(x) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use __ (Per 21 CFR 801.109)
(Optional Format 1-2-96)