(14 days)
ST AIA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The ST AIA-PACK CA 125 is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CA 125 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CA 125 concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The provided document is a 510(k) summary for the ST AIA-PACK CA 125 device, which is an in vitro diagnostic assay. It primarily describes the device, its intended use, and its substantial equivalence to a predicate device.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies.
The 510(k) is for a modification to an already cleared device (K990431), specifically concerning changes in packaging and incubation period. The submission argues that these modifications "are not substantial changes and do not affect the safety and effectiveness of the device." Therefore, it likely relies on the performance data of the original predicate device rather than presenting new, detailed performance studies for clinical acceptance criteria.
Without this information, I cannot complete the table or answer the specific questions thoroughly. However, I can infer some general aspects from the document’s purpose.
Here's an attempt to answer based on the lack of information in the provided text and what a 510(k) generally entails:
1. Table of Acceptance Criteria and Reported Device Performance
(This information is not explicitly provided in the document. A 510(k) summary for a modification often refers to the performance of the predicate device rather than presenting new data. For a full new device clearance, such data would be expected.)
| Acceptance Criteria Category | Specific Criteria (Expected for IVD) | Reported Device Performance (Not present in document) |
|---|---|---|
| Accuracy | Correlation with predicate device, recovery studies | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Precision (Repeatability/Reproducibility) | Within-run, between-run, between-lot CV% | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Linearity/Assay Range | Acceptable linearity across reportable range | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Analytical Sensitivity | Limit of Detection (LoD), Limit of Quantitation (LoQ) | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Specificity | Interference, cross-reactivity | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Stability | Reagent, calibrator, sample stability | (Likely demonstrated as unchanged from predicate, but not detailed here) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. Given it's a 510(k) for a modification (packaging and incubation period) and refers to "substantial equivalence" to a predicate, it's highly probable that new clinical test sets were not used. The focus is on demonstrating that the modification does not alter the established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For an in vitro diagnostic (IVD) assay like this, "ground truth" typically refers to the analytical performance (e.g., accuracy against a reference method or established clinical cut-offs), not expert consensus on images or clinical diagnoses for a test set.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. This method is usually relevant for human-interpreted data (e.g., radiology reads) where discrepancies between reviewers need to be resolved. For an automated IVD assay, the 'judgment' is algorithmic based on predefined analytical parameters.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is an IVD assay measuring a biomarker (CA 125), not an imaging device or AI-assisted diagnostic tool that involves human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The device is a standalone diagnostic assay (an immunoenzymometric assay). Its performance is evaluated analytically (accuracy, precision, etc.) and its use is "as an aid in monitoring response to therapy." The document implies that the performance characteristics (which would have been established for the predicate device) remain unchanged with the modification. However, specific standalone performance study results for the modified device are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in this document. For a CA 125 assay, the "ground truth" for analytical performance studies typically involves:
- Reference materials/calibrators: Samples with known concentrations of CA 125 for accuracy and linearity.
- Patient samples: Often used in method comparison studies against a legally marketed predicate device or a gold standard method.
- Clinical correlation: Evaluating the assay's ability to monitor therapeutic response in patients with ovarian cancer, often in conjunction with other clinical methods and patient outcomes.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. As an immunoenzymometric assay, it is not an AI/machine learning model that requires a "training set" in the conventional sense. The assay works based on established biochemical principles and reagents.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. (See answer to #8). The device's operational parameters (e.g., standard curve construction) are established through a calibration process, not "training" with a labeled dataset.
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DEC 0 6 2002 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| Submitter: | Tosoh Medics, Inc.347 Oyster Point Blvd., Suite 201South San Francisco, CA 94080Phone: (650) 615-4970Fax: (650) 615-0415 |
|---|---|
| Contact Person: | Lois NakayamaManager, Quality Assurance |
| Date of Summary Preparation: | November 8, 2002 |
| Device Name: | ST AIA-PACK CA 125 |
| Classification Name: | Test, Epithelial Ovarian Tumor-Associated Antigen |
| Predicate Device: | Tosoh AIA-PACK CA 125Tosoh CorporationTokyo, JapanK990431 |
Device Description:
The ST AIA-PACK CA 125 is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CA 125 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CA 125 concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
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Statement of Intended Use:
ST AJA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Substantial Equivalence:
This Special 510(k) is for a modification in the packaging and incubation period of the AIA-PACK CA 125. which was previously cleared as K990431 on June 3, 1999. The intended use, assay principles, antibody type, analyte detected, and performance characteristics of both assays are equivalent.
Conclusion:
The modified ST AIA-PACK CA 125, as described in this Special 510(k) is substantially equivalent to the predicate device. The proposed modifications in packaging and incubation period are not substantial changes and do not affect the safety and effectiveness of the device.
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. DEPARTMENT OF HEALTH & HUMAN SERVICES
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Re:
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Lois Nakayama Manager, Quality Assurance Tosoh Medics, Inc. 347 Oyster Point Boulevard, Suite 201 South San Francisco, California 94080
DEC 0 6 2002
K023891 -Trade/Device Name: ST AIA-PACK CA 125 Regulation Number: 21 CFR § 866.6010 Regulation Name: Test, Epithelial Ovarian Tumor-Associated Antigen Regulatory Class: II Product Code: LTK Dated: November 20, 2002 Received: November 22, 2002
Dear Ms. Nakayama:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman
Steven I. Gutman, M.D., M.B.A Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| Device Name | ST AIA-PACK CA 125 Enzyme Immunoassay |
|---|---|
| Indications forUse | ST AIA-PACK CA 125 is designed for IN VITRODIAGNOSTIC USE ONLY for the quantitativemeasurement of CA 125 in human serum on specificTOSOH AIA System analyzers. ST AIA-PACK CA 125 isto be used as an aid in monitoring response to therapyfor patients with epithelial ovarian cancer. Serial testingfor patient CA 125 assay values should be used inconjunction with other clinical methods used for monitoringovarian cancer. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. Reeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023891
سنيPrescription Use (Per 21CFR 801.109) OR
Over-The-Counter Use_
§ 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.