(68 days)
Not Found
No
The device description details a standard immunometric assay and the associated instrumentation. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis focuses on chemical reactions and light detection, not algorithmic learning or pattern recognition.
No.
This device is an in vitro diagnostic (IVD) assay designed to measure a specific antigen (CA19-9) in human serum and plasma to aid in the management and monitoring of patients with pancreatic cancer. It does not treat or cure any condition.
Yes
The device is designed for the in vitro quantitative measurement of a specific antigen to aid in the management of patients diagnosed with and monitoring the disease status of cancers of the exocrine pancreas. This places it directly in the realm of diagnostic devices used to assess a patient's health condition.
No
The device description clearly outlines hardware components (VITROS Immunodiagnostic System instrumentation) and reagent kits necessary for performing the assay, indicating it is 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 "For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma...". The term "in vitro" is the defining characteristic of an IVD.
- Device Description: The description details an "immunometric assay" performed on human serum and plasma samples using specific reagents and instrumentation. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The document describes studies evaluating the performance of the assay using human specimens (serum and plasma).
Therefore, based on the provided information, the VITROS CA 19-9 assay is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reagent Kit
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 CA 19-9 assay can be used to monitor the disease status in patients with chronic 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.
Calibrator Kit
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin).
Range Verifier Kit
For in vitro use in verifying the calibration range of the VITROS Immundiagnostic System when used for the measurement of 1116-NS-19-9 defined antigen.
Product codes (comma separated list FDA assigned to the subject device)
NIG, JIT, JJX
Device Description
The VITROS CA 19-9 assay is performed using the VITROS CA 19-9 Reagent Kit and the Immunodiagnostic System. An immunometric CA 19-9 assay is based on antigen present in the sample reads with a biotinylated antibody (mouse monoclonal anti-1116-NS-19-9 defined antigen). The antigen blouilylated antibody on the wells, unbound materials are removed by washing. In a second incubation a horseradish peroxidase (HRP)-labeled antibody binds to the immobilized Conjugate. 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 catalyzes the oxidation of the luminol to the wells. The electron transfer agent (a substituted acetanilide) increases the level of light produced and problemge bound 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 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).
- 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).
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical and Hospitals laboratories
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)
Comparison Study:
Study Type: Correlation analysis
Sample Size: 176 specimens
Key Results: The Passing-Bablok regression analysis comparing the VITROS CA 19-9 assay to the Fujireblo Diagnostics, Inc. OA 15 5 K.A. resulted in a slope of 0.83 (95% confidence interval of 0.80, 0.88) and an intercept of -4.02 (95% confidence interval of -4.3, 0.27).
Pancreatic Cancer Serial Specimens:
Study Type: Longitudinal analysis of CA 19-9 marker value and disease state change.
Sample Size: 74 patients with a total of 261 evaluable observations (average 3.5 observations per patient).
Key Results:
- Total Concordance: C = (15+96) / 187 = 111/187 = 59.4%
- Positive Concordance: C+ = 15/33 = 45.5%
- Negative Concordance: C- = 96/154 = 62.3%
Per Patient Analysis:
Study Type: Per-patient analysis of concordance between change in CA 19-9 and change in disease state.
Sample Size: 74 patients
Key Results:
- Estimates of Per-Patient Positive, Negative and Total Concordance with 95% Confidence Intervals:
- Total Concordance (C): Estimate = 66.22%, Lower Bound = 54.28%, Upper Bound = 76.81%
- Positive Concordance (C+): Estimate = 68.18%, Lower Bound = 45.13%, Upper Bound = 86.14%
- Negative Concordance (C-): Estimate = 65.38%, Lower Bound = 50.91%, Upper Bound = 78.03%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Concordance (Total, Positive, Negative) was reported.
Total Concordance: 59.4%
Positive Concordance: 45.5%
Negative Concordance: 62.3%
Per-Patient Concordance:
Total Concordance: 66.22%
Positive Concordance: 68.18%
Negative Concordance: 65.38%
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
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 Parkway
Malvern, 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 Pack
VITROS Immunodiagnostics Products CA 19-9 Calibrators
VITROS Immunodiagnostics Products CA 19-9 Range Verifiers |
| Common/Usual Name: | CA 19-9 Assay |
| Classification Name: | System, Test, Carbohydrate Antigen (CA19-9), For Monitoring
And 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.
1
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.
2
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.
3
| | Ortho Clinical Diagnostics
VITROS Immunodiagnostic
Products 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 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
CA19-9 test results should be
used in conjunction with all other
available clinical and laboratory
data before a medical decision is
determined. | The Fujirebio Diagnostics CA 19-
9™ RIA, an in vitro diagnostic test
for the quantitative measurement
of the CA 19-9 tumor associated
antigen, in human serum or
plasma, is indicated for the serial
measurement of CA 19-9 to aid in
the management of patients
diagnosed with cancers of the
exocrine pancreas. The test is
useful to aid in:
Monitoring of disease status in
those patients having confirmed
pancreatic cancer who have levels
of serum or plasma CA 19-9 above
the cutoff, at the time of diagnosis.
CA 19-9 values must be
interpreted in conjunction with all
other clinical and laboratory data
before a medical decision is
determined. |
| Type of Specimen | Human serum or plasma (EDTA,
Sodium and Lithium Heparin) | Human Serum or Plasma (Citrate,
Heparin, ACD-A or EDTA) |
| Specimen Collection
Method | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Capture Antibody | 1116-NS-19-9 (F(ab')2) mouse
monoclonal | 1116-NS-19-9 mouse monoclonal |
| Conjugate Antibody | 1116-NS-19-9 (F(ab')2) mouse
monoclonal | 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 |
4
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 |
| 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
6
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
8
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