(68 days)
For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin). The VITROS CA19-9 assay is to be used to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The VITROS CA19-9 assay can be used to monitor the disease status in patients with confirmed pancreatic cancer who show measurable CA19-9 values over the course of their disease. Serial CA 19-9 test results should be used in conjunction with all other available clinical and laboratory data before a medical decision is determined.
The VITROS CA 19-9 assay is performed using the VITROS CA 19-9 Reagent Kit and the VITROS Immunodiagnostic System. An immunometric assay is performed. CA 19-9 antigen present in the sample reacts with a biotinylated antibody (mouse monoclonal anti-1116-NS-19-9 defined antigen). The antigen-biotinylated antibody complex binds to the wells, unbound materials are removed by washing. In a second incubation a horseradish peroxidase (HRP)-labeled antibody Conjugate (mouse monoclonal anti-1116-NS-19-9 defined antigen) binds to the immobilized complex. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic Substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP Conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs the emission. The light signals are read by the system. The light produced is directly proportional to the concentration of 1116-NS-19-9 defined antigen present.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CA 19-9 Reagent Pack, VITROS Immunodiagnostic Products CA 19-9 Calibrator Kit, and the VITROS Immunodiagnostic Products CA 19-9 Range Verifier Kit, which are used by the VITROS Immunodiagnostic System to perform the VITROS CA 19-9 assay).
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
- Common Reagent Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent, which were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document provided does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the device's performance in clinical application (e.g., specific sensitivity/specificity targets). Instead, it focuses on demonstrating substantial equivalence to a predicate device and showing an association between changes in marker value and changes in disease state.
The "reported device performance" section focuses on the concordance between changes in the VITROS CA 19-9 assay and changes in the disease state for pancreatic cancer patients.
| Area of Evaluation | Reported Device Performance (%/Value) |
|---|---|
| Comparison Study (vs. Predicate Device) | |
| Passing-Bablok Regression | Slope: 0.83 (95% CI: 0.80, 0.88) |
| Intercept: -4.02 (95% CI: -4.3, 0.27) | |
| Pearson's Correlation (r) | 0.93 (95% CI: 0.91, 0.95) |
| Pancreatic Cancer Serial Specimens Study | |
| Association between Change in Marker Value and Change in Disease State (per observation pair) | |
| Total Concordance ($C$) | 59.4% (111/187 observation pairs) |
| Positive Concordance ($C_+$) | 45.5% (15/33 observation pairs where disease progressed and marker increased) |
| Negative Concordance ($C_-$) | 62.3% (96/154 observation pairs where disease did not progress and marker did not increase) |
| Per-Patient Analysis of Concordance | |
| Total Concordance ($C$) | Estimate: 66.22% (95% CI: 54.28% - 76.81%) |
| Positive Concordance ($C_+$) | Estimate: 68.18% (95% CI: 45.13% - 86.14%) (Proportion of patients with disease progression also showing CA 19-9 increase) |
| Negative Concordance ($C_-$) | Estimate: 65.38% (95% CI: 50.91% - 78.03%) (Proportion of patients with no disease progression also showing no CA 19-9 increase) |
2. Sample Size Used for the Test Set and Data Provenance
- Comparison Study (vs. Predicate):
- Sample Size: 176 specimens.
- Data Provenance: Not explicitly stated, but given the context of a 510(k) summary for a US submission, it is likely to be a combination of retrospective samples or samples collected specifically for this validation. The document does not specify country of origin.
- Pancreatic Cancer Serial Specimens Study:
- Sample Size: 74 patients, yielding 261 evaluable observations (average 3.5 observations per patient) and 187 observation pairs for the change analysis.
- Data Provenance: Not explicitly stated, but inferred to be clinical data. The document does not specify country of origin or if it's retrospective/prospective. It mentions "staging was available from the chart," suggesting retrospective chart review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish the ground truth for the test set in either the comparison study or the pancreatic cancer serial specimens study.
- In the comparison study, the ground truth is implicitly the result from the predicate device (Fujirebio Diagnostics, Inc. CA 19-9 RIA).
- In the pancreatic cancer serial specimens study, the "Change in Disease State (Progression / No Progression)" is the ground truth. The method for determining this change is not detailed but would typically come from clinical assessments (e.g., imaging, clinical symptoms, physician's diagnosis), not expert consensus based on re-reading.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either study to establish ground truth or assess discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The device is an in vitro diagnostic assay, not an imaging device typically evaluated with MRMC studies or human reader performance. The "effectiveness" is shown through clinical correlation and substantial equivalence to a predicate, not through human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance evaluations of the assay itself. The device is a laboratory assay (VITROS CA 19-9), and its performance is measured directly, without human interpretation or adjustment influencing the assay's output. The output (CA 19-9 value) is then interpreted by clinicians in conjunction with other data.
7. The Type of Ground Truth Used
- Comparison Study: The "ground truth" was the results obtained from the predicate device (Fujirebio Diagnostics, Inc. CA 19-9 RIA).
- Pancreatic Cancer Serial Specimens Study: The "ground truth" was the clinical determination of disease state change (Progression vs. No Progression). This likely came from a composite of clinical factors, imaging, and physician assessment, rather than a single direct measure like pathology at every time point for all patients.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For an IVD assay like this, development typically involves method development and verification using various samples, but a formally defined "training set" in the machine learning sense is not applicable. The studies described are performance validation studies.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned in the context of machine learning, this question is not directly applicable. For the development and verification of the assay itself, the ground truth would have been established through well-characterized reference materials, known concentrations, and comparisons to established methods during the research and development phases.
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510(k) SUMMARY
DEC 2 0 2005
This summary of 510(k) safety and effectiveness information is being submitted in This Summary of STO(if) See(if) Seeks, of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K052889.
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.201 Great Valley ParkwayMalvern, PA 19355 |
|---|---|
| Contact person: | Diana L. Wolaniuk, (610) 240-3917 |
| Summary preparation date: | December 12, 2005 |
| Name of Device | |
| Trade/Proprietary Name: | VITROS Immunodiagnostics Products CA 19-9 Reagent PackVITROS Immunodiagnostics Products CA 19-9 CalibratorsVITROS Immunodiagnostics Products CA 19-9 Range Verifiers |
| Common/Usual Name: | CA 19-9 Assay |
| Classification Name: | System, Test, Carbohydrate Antigen (CA19-9), For MonitoringAnd Management Of Pancreatic Cancer |
| Predicate Device |
Fujirebio Diagnostics, Inc. CA 19-9 RIA
Device Description
The VITROS CA 19-9 assay is performed using the VITROS CA 19-9 Reagent Kit and the The VITROD OA 16 0 accuse to periodia Immunodiagnostic System. An immunometric CA 19-9 Callorator All on the VITAS on antigen present in the sample reads with a biotinylated antibody (mouse monoclonal anti-1116-NS-19-9 defined antigen). The antigenblouilylated antibody (mouse monooming on the wells, unbound materials are removed by In a second incubation a horseradish peroxidase (HRP)-labeled antibody washing. washing. In a second "house monoclonal antigen) binds to the immobilized Conjugate (modal mondonal anti-bound conjugate is removed by washing. The bound THRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic HKF Conjugate is measured by a lammessed salt) and an electron transfer agent, is added Substrates (a laminor denvative and a placoniyate catalyzes the oxidation of the luminol to the wells. "The The electron transfer agent (a substituted acetanilide) increases denvalve, producing light. The elobiled the emission. The light signals are read by the the level of light produced and problemge bound is directly proportional to the concentration of 1116-NS-19-9 defined antigen present.
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The system is comprised of three main elements:
- il is comprised of three main Siements.
The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic PA 10 A 1. The VTROS Immanodiagnostion Pack, VITROS Immunodiagnostic Products CA 19-9 Products CA 19 5 Reagonic Pass, Immunodiagnostic Products CA 19-9 Range Calibrator Kit, and the vitness by the VITROS Immunodiagnostic System to perform the VITROS CA 19-9 assay). - pendin the VITROS Immunodiagnostic System instrumentation, which provides 2. The VITROS Infinitioulaghoodio Cyter The VITROS Immunodiagnostic System
automated use of the immunoassay kits. The VITROS Immunous automated use of the thinaneasonal e 510(k) premarket notification (K962919). - was cleared for manot by a coparate on ( ) ( ) ( ) ( ) ( ) ) ( The VITROS 3. Common Cagonto Products Signal Reagent and VITROS Immunodiagnostic Infinunodiagnostic - Freducts - Freducts - Frant of the VITROS Immunodiagnostic Products Total T3 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically only for use with the WITROS Immunodiagnostic Products range of immunoassay products.
Intended Use
Reagent Kit
Readent III
For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in the the For the in Viro quantilatio model on one VITROS CA19-9 assay is to be used to aid in the and plasma (LDTA of nepanin). ed noth cancers of the exocrine pancreas. The VITEOS . management of patients alagnood mitor the disease status in patients with confirmed CA19-9 assay can be dood to monthle CA19-9 values over the course of their disease. paricleatic career who show measurable in conjunction with all other available clinical and laboratory data before a medical decision is determined.
Calibrator Kit
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the Por 7/1 Viro use in the Sambration 31-9 defined antigen in human serum and plasma (EDTA or heparin).
Range Verifier Kit
Kange vehiles in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of 1116-NS-19-9 defined antigen.
- Patients known to be genotypically negative for the Lewis blood group antigen WARNING: will be unable to produce the CA 19-9 antigen even in the presence of will be unable to producing for the presence of the Lewis antigen may be manghant to detect true Lewis antigen negative individuals. Even patients insumelent to dotootypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.
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Statement of Substantial Equivalence
For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in human serum For the in vilro quantitative measurement of 1110 No 10 essay is to be used to aid in the and plasma (EDTA of nepallin). The virroo of the exocrine pancreas. The VITROS management of patients diagnosed with cathorio on patients with confirmed CA19-9 assay can be tiscu to monitor the are and the course of their disease. panceatic cancer who show measurable of tro o read in conjunction with all other available clinical and laboratory data before a medical decision is determined.
VITROS CA 19-9 Assay kit is substantially equivalent to Fujirebio Diagnostics, Inc. CA 19-9 S OF 19-J Assay Kit is oubstantially of creating and are indicated for the quantitative RIA. Rin. - Both of the Gevices and 145-19-9 reactive determinants) and as aids in monitoring disease status for patients with pancreatic cancer.
A comparison of the features of the VITROS CA 19-9 Assay device and the Fujirebio Diagnostics, Inc. CA 19-9 RIA follows.
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| Ortho Clinical DiagnosticsVITROS ImmunodiagnosticProducts CA 19-9™ Assay(Proposed Device) | Fujirebio Diagnostics, Inc.CA 19-9™ RIA(Predicate Device)K020566 | |
|---|---|---|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and | Class II, NIG | Class II, NIG |
| Product Code | ||
| Principle of Operation | Enzymatic Immunoassay (EIA) | Radioimmunoassay (RIA) |
| Product Usage | Clinical and Hospitals laboratories | Clinical and Hospitals laboratories |
| Intended Use | For the in vitro quantitativemeasurement of 1116-NS-19-9defined antigen in human serumand plasma (EDTA or heparin).The VITROS CA19-9 assay is tobe used to aid in the managementof patients diagnosed with cancersof the exocrine pancreas. TheVITROS CA19-9 assay can beused to monitor the disease statusin patients with confirmedpancreatic cancer who showmeasurable CA19-9 values overthe course of their disease. SerialCA19-9 test results should beused in conjunction with all otheravailable clinical and laboratorydata before a medical decision isdetermined. | The Fujirebio Diagnostics CA 19-9™ RIA, an in vitro diagnostic testfor the quantitative measurementof the CA 19-9 tumor associatedantigen, in human serum orplasma, is indicated for the serialmeasurement of CA 19-9 to aid inthe management of patientsdiagnosed with cancers of theexocrine pancreas. The test isuseful to aid in:Monitoring of disease status inthose patients having confirmedpancreatic cancer who have levelsof serum or plasma CA 19-9 abovethe cutoff, at the time of diagnosis.CA 19-9 values must beinterpreted in conjunction with allother clinical and laboratory databefore a medical decision isdetermined. |
| Type of Specimen | Human serum or plasma (EDTA,Sodium and Lithium Heparin) | Human Serum or Plasma (Citrate,Heparin, ACD-A or EDTA) |
| Specimen CollectionMethod | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Capture Antibody | 1116-NS-19-9 (F(ab')2) mousemonoclonal | 1116-NS-19-9 mouse monoclonal |
| Conjugate Antibody | 1116-NS-19-9 (F(ab')2) mousemonoclonal | 1116-NS-19-9 mouse monoclonal |
| Standards/Calibrators | 3 levels (1 = 15 U/mL, 2 = 60, 3 =700 U/mL) | 6 levels (0 - 240 U/mL) |
| Interpretation of Results | Calibrator Curve | Standard Curve |
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Comparison Study
A total of 176 specimens were evaluated for the correlation analysis using the VITROS CA A total of Tro Specificits were evaluatics, Inc. CA 19-9 RIA. The VITROS CA 19-9 assay and 19-9 assay and the Fujirebio Diagnostics, find of the Fujirebio Diagnostics CA 19-9 RIA assay specimen range was 2.36 - 892 U/mL.
The Passing-Bablok regression analysis comparing the VITROS CA 19-9 assay to the The Passing-Bablok Tegression analysio Johnsamig - of 0.83 (95% confidence interval Fujireblo Diagnostics, Inc. OA 15 5 K.A. 155% confidence interval of -4.3, 0.27).
of 0.80, 0.88) and an intercept of -4.02 (95% confidence interval of -4.02 (4.0.000) The of 0.00, 0.00) and an intercopt of 1.0.000 (05% confidence interval of 0.91, 0.95).
Pancreatic Cancer Serial Specimens
This analysis is based on 74 patients. There were a total of 261 evaluable observations. The average number of observations per patient is 3.5.
The average age of the subjects at time of diagnosis was 61.8 years (Exact 55% Cl: 59.5 The average age of the subjects at time of analysis five percent (55% or 4174) of the 74 years to 64.1 years) with a fange of 41 to ob your cross (45% or 33/74) were women. Staging patients were frien and the remaining forty from the majority of the patients were stage was available from the chart for 10 or the 11 patiently were stage I and II 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 A 2x2 table was construction to onew the esse from one observation to the next. A significant CA 19-9 value and progression of the disouse inchi od as at least a 12.5% increase in assay positive change in VTTXOO OF To o loven 1.86V of the test]. The following table (entitled value [at Teast 2.3 times greater than the for the 187 observation pairs in this study.
Three estimates of Concordance are given for the following Table.
| Total Concordance: | $C = (15+96) / 187 = 111/187 = 59.4%$ |
|---|---|
| Positive Concordance: | $C_{+} = 15/33 = 45.5%$ |
| Negative Concordance: | $C_{-} = 96/154 = 62.3%$ |
| 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |||
|---|---|---|---|
| Change in CA 19-9 | Change in Disease State (W) | ||
| W | Progression | No Progression | Total |
| > 12.5% | 15 | રેક | 73 |
| < 12.5% | 18 | તેન્દ | 114 |
| Total | 33 | 154 | 187 |
Distribution of W by V
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Per Patient Analysis
Per Patient Analysis
The table below (entitled " Per Patient Distribution) demonstrates this distribution for the 74 patients in this study.
| Per-Patient Distribution | ||||
|---|---|---|---|---|
| Change in Disease State | ||||
| Change in CA 19-9 | Progression | No Progression | Total | |
| ≥ 12.5% | 15 | 18 | 33 | |
| < 12.5% | 7 | 34 | 41 | |
| Total | 22 | 52 | 74 | |
Confidence intervals for these Estimates of per-patient concordances can be obtained. Estimates or per-patient concordantes can bo distribution. The following table (entitled estimates can be determinou acing the bir oncordance with 95% onfidence Estimate of Per- ation Toolino, Nogano, Shares and 95% confidence intervals about each estimate.
Estimates of Per-Patient Positive, Negative and Total Concordance with 95% Confidence Intervals
| Statistic | Estimate | Lower Bound | Upper Bound |
|---|---|---|---|
| C | 66.22% | 54.28% | 76.81% |
| C+ | 68.18% | 45.13% | 86.14% |
| C | 65.38% | 50.91% | 78.03% |
In addition to the studies mentioned above, tests were performed to obtain analytical In addition to the studies mentioned above, tools from proced values. Refer to the VITROS Seristivity, Spocillery, prons For Use for VITROS CA 19-9 assay results
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Fujirebio Diagnostics, Inc. c/o Ms. Diana L. Wolaniuk Clinical and Regulatroy Affairs Specialist 201 Great Valley Pkwy, Malvern, PA 19355-1307
DEC 2 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K052889
KUS2889
Trade/Device Name: VITROS Immunodiagnostics Products CA 19-9™ Calibrators VITROS Immunodiagnostics Products CA 19-9™ Calibrators VITROS Immunodiagnostics Products CA 19-9TM Range Verifiers Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated Antigen Immunological Test System Regulatory Class: Class II Product Code: NIG, JIT, JJX Dated: October 11, 2005 Received: October 13, 2005
Dear Ms. Wolaniuk:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 510(x) premarker is substantially equivalent (for the indications for referenced above and nave accemined the are are devices marketed in interstate comments devices they use stated in the encrosure) to regally maneces presentation in the Medical Devices that prob to May 26, 1970, file chacinent date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal - (MA) - Your may have been reclassified in accordance with are portication (PMA). The prove Act (Act) that do not require approval or a provisions of the Act . The general therefore, market the device, subject to the general semi- personation, listing of devices, good controls provisions of the Networks of this against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (Sec above) this example regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Oode of recoming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualled of a substance of a substance requirement of the Act of that FDA has made a determination that your active complex. You must comply with any Federal Statures and regulations administered of Sammers of CFR Part 807); all the Act s requirements, meruding, but not interest as set forth in the quality labeling (21 CFR Part 001), good namazations policable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable to 1950 systems (QB) 10gations 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manteeing your and equivalence of your device to legally
{7}------------------------------------------------
Page 2 –
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 of questions on the promise Evaluation and Safety at (240) 276-0484. Also, please note the Vitto Diagnostic Dorter Drading by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may ooann other generational 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/industry/support/index.html
Sincercly yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052889
Device Name: VITROS CA 19-9TM
Indications For Use:
Reagent Kit
Reagent KIT
For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in human For the in vitro quantitative measurenical of TTP S CA19-9 assay is to be used to aid
serum and plasma (EDTA or heparin). The VITROS CA19-9 assay is to be used to ad serum and plasma (EDTA of nepalin). The Virth excers of the excerine pancreas. The
in the management of patients diagnosed with ellinges artus in patients with in the management of patients diagnood with chiesase status in patients with VITRUS CA 19-9 assay can be used to mensurable CA19-9 values over the course of
confirmed pancreatic cancer who show measurable contrinction with all other confirmed panceatic cancer will show modellable of Art in conjunction with all other
their disease. Serial CA 19-9 test results should be used in conjunction is netermined their disease. Senal OA 19-3 tool rooms are and its and in the determined.
Calibrator Kit
Calibrator K.I
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the For in viro use in the calibration of the VTACO innuments
quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin).
Range Verifier Kit
Range verilier Kill
For in vitro use in verifying the calibration range of the VITROS Immundiagnostic For in villo use in vehiying the oalibration raily of 1116-NS-19-9 defined antigen.
V Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Trina Chan
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
510(k) K052889
§ 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.