ARCHITECT CA 19-9XR ASSAY

K052000 · Fujirebio Diagnostics,Inc. · NIG · Oct 25, 2005 · Immunology

Device Facts

• Record ID: K052000
• Device Name: ARCHITECT CA 19-9XR ASSAY
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: NIG · Immunology
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The ARCHITECT® CA 19-9™_XR assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants inhuman serum and plasma on the ARCHITECT i System. The ARCHITECT® CA 19-9™_XR assay is to be used as an aid in the management of pancreatic cancer patients with a detectable level of Ca 19-9 at some point in their disease process and in conjunction with other clinical methods. The ARCHITECT® CA 19-9™_XR Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 1116-19-9 reactive determinants in human serum and plasma. Refer to the ARCHITECT® CA 19-9™ₓₗ reagent package insert for additional information. The ARCHITECT® CA 19-9™ₓₗ Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum and plasma. Refer to the ARCHITECT® CA 19-9™ₓₗ reagent package insert for additional information.

Device Story

The ARCHITECT CA 19-9xR assay is a two-step chemiluminescent microparticle immunoassay (CMIA) performed on the ARCHITECT i System. It measures 1116-NS-19-9 reactive determinants in human serum or plasma. In the first step, patient samples are combined with 1116-NS-19-9 coated paramagnetic microparticles. After washing, an acridinium-labeled 1116-NS-19-9 conjugate is added. Following a second wash, trigger solutions are added to initiate a chemiluminescent reaction, measured as relative light units (RLUs). The RLU output is directly proportional to the concentration of 1116-NS-19-9 reactive determinants. The device is used in clinical and hospital laboratories by trained personnel. Results are interpreted by clinicians alongside other clinical and laboratory data to monitor disease status in patients with confirmed pancreatic cancer. The assay provides quantitative data to assist in managing patient care and assessing disease progression.

Clinical Evidence

Clinical performance was evaluated using 259 serum specimens comparing the ARCHITECT CA 19-9xR assay to the predicate RIA. Passing-Bablok regression showed a correlation coefficient of 0.96. Reproducibility studies (total precision %CV) were ≤ 10%. A serial specimen study of 74 pancreatic cancer patients (261 observations) assessed the association between marker changes and disease state, reporting a total concordance of 61.0% (95% CI: 57.10% - 79.17%) for changes ≥ 14.0%. Reference ranges were established using 360 apparently healthy subjects.

Technological Characteristics

CMIA technology; uses 1116-NS-19-9 mouse monoclonal capture and F(ab')2 conjugate antibodies. Energy source: chemiluminescent reaction measured by ARCHITECT i System optics. Connectivity: integrated with ARCHITECT i System. Software: automated RLU-to-concentration calculation via calibration curve. Form factor: reagent kit for automated analyzer.

Indications for Use

Indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the pancreas. Serial testing for patient CA 19-9ₓₗ assay values is used in conjunction with other clinical methods in the management of pancreatic cancer patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fujirebio Diagnostics, Inc. CA 19-9 RIA (K020566)

Submission Summary (Full Text)

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## 007 2 5 2005 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This Sammary with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __ OS2دهده (

## Submitter Information

| Address: | Fujirebio Diagnostics, Inc.<br>201 Great Valley Parkway<br>Malvern, PA 19355 |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Contact person: | Diana L. Wolaniuk, [phone] |
| Summary preparation date: | October 25, 2005 |
| Name of Device | |
| Trade/Proprietary Name: | ARCHITECT® CA 19-9™XR Assay |
| Common/Usual Name: | CA 19-9 Assay |
| Classification Name: | System, Test, Carbohydrate Antigen (CA19-9), For Monitoring<br>And Management Of Pancreatic Cancer |
| Predicate Device | Fujirebio Diagnostics, Inc. CA 19-9 RIA |

### Device Description

The ARCHITECT CA 19-9xR assay is a two-step immunoassay for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

In the first step, sample and 1116-NS-19-9 coated paramagnetic microparticles are combined. 1116-NS-19-9 reactive determinants present in the sample bind to the 1116-NS-19-9 coated microparticles. After washing, 1116-NS-19-9 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of 1116-NS-19-9 reactive determinants in the sample and the RLUs detected by the ARCHITECT i System optics.

For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.

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#### Intended Use

#### Reagent Kit

The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay The ARCHITECT OF 15 SXF doody to a Shorts -19-9 reactive determinants in human (CMIA) for the qualificatio dotorminative i System. The ARCHITECT CA 19-9xR assay is to be serum of plasma on the Arcorn EST pancreatic cancer patients in conjunction with other clinical methods.

Patients known to be genotypically negative for the Lewis blood group antigen will be unable Fallents known to be genotyploany nogation for seence of malignant tissue. Phenotyping for to produce the OA 10 0 anligen may be insufficient to detect true Lewis antigen negative the presence of the Eowlo antigon may of the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.

#### Calibrator Kit

The ARCHITECT CA 19-9xp Calibrators are for the calibration of the ARCHITECT i System The AROMITED OF OF TO OX Calleration of 1116-NS-19-9 reactive determinants in when used for the qualitian. Refer to the ARCHITECT CA 19-9xe reagent package insert for additional information.

#### Control Kit

The ARCHITECT CA 19-9xR Controls are for the estimation of test precision and the The ARCHITEOT OF 15 ox 30 ox Sentralia and the ARCHITECT i System (reagents, delection of Systemation and for the quantitative measurement of 111-NS-19-9 canbrutors, and instruments in human serum or plasma. Refer to the ARCHITECT CA 19-9xR reagent package insert for additional information.

#### Statement of Substantial Equivalence

The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human (Onlin) for the quantitiatio assessment i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.

ARCHITECT CA 19-9 Assay kit is substantially equivalent to the Fujirebio Diagnostics, Inc. CA 19-9 RIA. Both of the devices are IVD products and are indicated for the quantitative determination of CA 19-9 assay values (1116-NS-19-9 reactive determinants) and used in conjunction with other clinical methods in the management of pancreatic cancer patients.

A comparison of the features of the ARCHITECT CA 19-9xR assay device and the Fujirebio Diagnostics, Inc. CA 19-9 RIA follows.

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| | Abbott Laboratories | Fujirebio Diagnostics, Inc. |
|----------------------------|-------------------------------------------------------------|-------------------------------------------------------------------|
| | ARCHITECT CA 19-9" xR Assay | CA 19-9™ RIA |
| | (Proposed Device) | (Predicate Device)<br>K020566 |
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and | Class II, NIG | Class II, NIG |
| Product Code | | |
| Principle of Operation | Chemiluminscent Microparticle | Radioimmunoassay (RIA) |
| | Immunoassay (CMIA) | |
| Product Usage | Clinical and Hospitals laboratories | Clinical and Hospitals laboratories |
| Intended Use | The ARCHITECT® CA 19-9 xr | The Fujirebio Diagnostics CA 19- |
| | assay is a chemiluminescent | 9 ™ RIA, an in vitro diagnostic test |
| | microparticle immunoassay | for the quantitative measurement |
| | (CMIA) for the quantitative | of the CA 19-9 tumor associated |
| | determination of 1116-NS-19-9 | antigen, in human serum or<br>plasma, is indicated for the serial |
| | reactive determinants in human | measurement of CA 19-9 to aid in |
| | serum or plasma on the | the management of patients |
| | ARCHITECT i System. The | diagnosed with cancers of the |
| | ARCHITECT CA 19-9xR assay is<br>to be used as an aid in the | exocrine pancreas. The test is |
| | management of pancreatic cancer | useful to aid in: |
| | patients in conjunction with other | Monitoring of disease status in |
| | clinical methods. | those patients having confirmed |
| | Patients known to be genotypically | pancreatic cancer who have levels |
| | negative for the Lewis blood group | of serum or plasma CA 19-9 above |
| | antigen will be unable to produce | the cutoff, at the time of diagnosis. |
| | the CA 19-9 antigen even in the | CA 19-9 values must be |
| | presence of malignant tissue. | interpreted in conjunction with all |
| | Phenotyping for the presence of | other clinical and laboratory data |
| | the Lewis antigen may be | before a medical decision is |
| | insufficient to detect true Lewis | determined. |
| | antigen negative individuals. | |
| | Even patients who are | |
| | genotypically positive for the | |
| | Lewis antigen may produce | |
| | varving levels of CA 19-9 based | |
| | on gene dosage effect. | Human Serum or Plasma (Citrate, |
| Type of Specimen | Human serum or plasma (Sodium, | Heparin, ACD-A or EDTA) |
| | Lithium or EDTA)<br>Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Specimen Collection | | |
| Method<br>Capture Antibody | 1116-NS-19-9 mouse monoclonal | 1116-NS-19-9 mouse monoclonal |
| Conjugate Antibody | 1116-NS-19-9 (F(ab')2) mouse | 1116-NS-19-9 mouse monoclonal |
| | monoclonal | |
| Standards | 6 levels (0 - 1200 U/mL) | 6 levels (0 - 240 U/mL) |
| Controls | 3 levels (Low = 40 U/mL, Medium | 2 levels (Low = 40-50 U/mL, High |
| | = 150 U/mL, High = 750 U/mL) | = 80-90 U/mL) |
| Interpretation of Results | Calibrator Curve | Standard Curve |

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## Summary of Performance characteristics

### Reproducibility:

Precision was determined as described in the National Committee for Clinical Laboratory Frecision was determinde as aboshibe in amples were tested consisting of two panels of Standards (NOOLO) 1 rollood LP ) . D = panel of serum to which 1116-NS-19-9 reactive determinants were added (panel 3), and the ARCHITECT CA 19-9xR Controls, using two lots uctemninatio word datos (panel of, wo separate times per day, for 20 nonconsecutive days or reagents, in rophiedlor of work lot used a single calibration curve throughout the study. on two maturnemo. Each teagoed by calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.

The total precision %CV of the ARCHITECT CA 19-9xp assay was determined to be less than or equal to 10%.

#### Comparison Study

A total of 259 serum specimens were tested using the ARCHITECT CA 19-9xx assay and the Fujirebio Diagnostics, Inc. CA 19-9 RIA. Passing-Bablok linear regression analysis was r affebrook on all specimens (2.0 - 9115.7 U/mL for the ARCHITECT CA 19-9xR assay and 1.17 - 10,782 U/mL for the Fujirebio Diagnostics, Inc. CA 19-9 RIA).

Passing-Bablok linear regression analysis comparing the ARCHITECT CA 19-9xR assay to the Fujirebio Diagnostics, Inc. CA 19-9 RIA yielded a correlation coefficient of 0.96, a slope of 1.2 (99% confidence interval of 1.08, 1.37), and Y-axis intercept of -5.1 U/mL (99% confidence interval of -7.4, -3.4).

### Reference Ranges:

### Apparently Healthy Population:

The distribution of CA 19-9xR assay values determined in 360 serum specimens from apparently healthy individuals is shown in the table below:

| Distribution of ARCHITECT CA 19-9xR Values | | | | | | |
|--------------------------------------------|-----------------------|------------------|--------------------|---------------------|----------------------|-------------|
| | | Percent (%) | | | | |
| | Number of<br>Subjects | 0 - 37.0<br>U/mL | 37.1 - 100<br>U/mL | 100.1 - 500<br>U/mL | 500.1 - 1200<br>U/mL | > 1200 U/mL |
| Apparently<br>Healthy<br>Subjects | 360 | 94.4% | 5.6% | 0.0% | 0.0% | 0.0% |

In this study, 94.4% of the specimens from apparently healthy subjects (n=360) had values of 37 U/mL or less.

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## Patient Groups:

The distribution of CA 19-9 assay values determined in 978 individual serum samples from The distinution of OA 15-5 assuy Value doceminoun in the table below:

| Distribution of ARCHITECT CA 19-9XR Values | | | | | | |
|--------------------------------------------|--------------------|---------------|-----------------|------------------|-------------------|-------------|
| | Number of Subjects | 0 - 37.0 U/mL | 37.1 - 100 U/mL | 100.1 - 500 U/mL | 500.1 - 1200 U/mL | > 1200 U/mL |
| Nonmalignant Disease | | | | | | |
| Rectal Polyps | 33 | 97.0% | 3.0% | 0.0% | 0.0% | 0.0% |
| Pancreatitis | 3 | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| Gallbladder | 21 | 95.2% | 0.0% | 0.0% | 0.0% | 4.8% |
| Diabetes | 38 | 94.7% | 5.3% | 0.0% | 0.0% | 0.0% |
| Pulmonary | 40 | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| Cirrhosis | 153 | 92.8% | 4.6% | 0.7% | 0.7% | 1.3% |
| Hepatitis | 68 | 92.6% | 7.4% | 0.0% | 0.0% | 0.0% |
| Renal | 34 | 91.2% | 8.8% | 0.0% | 0.0% | 0.0% |
| Other<br>Gastrointestinal | 51 | 96.1% | 3.9% | 0.0% | 0.0% | 0.0% |
| Malignant Disease | | | | | | |
| Colorectal | 169 | 81.1% | 7.7% | 5.3% | 1.2% | 4.7% |
| Pancreatic | 66 | 43.9% | 6.1% | 12.1% | 10.6% | 27.3% |
| Gastric | 69 | 66.7% | 11.6% | 10.1% | 2.9% | 8.7% |
| Hepatocellular | 30 | 63.3% | 16.7% | 3.3% | 10.0% | 6.7% |
| Pulmonary | 70 | 84.3% | 5.7% | 4.3% | 1.4% | 4.3% |
| Mammary | 102 | 86.3% | 10.8% | 2.0% | 1.0% | 0.0% |
| Ovarian | 31 | 87.1% | 6.5% | 3.2% | 3.2% | 0.0% |

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## 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 oubjock at the 85 years. Fifty-five percent (55% or 41/74) of the 74 years to o4.1 years) with a range of 17 try-five percent (45% or 33/74) were women. Staging patients were from the the romaining the 74 patients. The majority of the patients were stage was available from the churclor 10 of the 4.1% and 6.8% were stage 1 and 11 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 obnothed to the disease from one observation to the next. A positive OA 19-9 value and progression of the value that is at least 2.5 times greater than the total %CV of the test. For the test assay this value is 14.0%. The following Table (entitled "Distribution of W by V") presents the results for the 187 observation pairs in this study.

Three estimates of Concordance are given for the following Table.

| Total Concordance: | $C = (16+98) / 187 = 114/187 = 61.0%$ |
|-----------------------|---------------------------------------|
| Positive Concordance: | $C_{+} = 16/33 = 48.5%$ |
| Negative Concordance: | $C_{-} = 98/154 = 63.6%$ |

| Distribution of W by V | | | |
|--------------------------|-----------------------------|----------------|-------|
| Change in CA 19-9<br>(V) | Change in Disease State (W) | | |
| | Progression | No Progression | Total |
| ≥ 14.0% | 16 | 56 | 72 |
| < 14.0% | 17 | 98 | 115 |
| Total | 33 | 154 | 187 |

#### Distribution of W by V

#### Per Patient Analysis

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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 |
| ≥ 14.0% | 15 | 16 | 31 |
| < 14.0% | 7 | 36 | 43 |
| Total | 22 | 52 | 74 |

#### Per-Patient Distribution

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Estimates of per-patient concordances can be obtained. The for these Estimates or per-patient concordances ban bo otableding table (entilled' estimates can be delemined using the binomia distribution of the sonfidence Estimate of Fel-Fatlent Fostine, Negative and Fotal Centre vals about each estimate.

# Estimates of Per-Patient Positive, Negative and Total Concordance with 95% Confidence Intervals

| Statistic | Estimate | Lower Bound | Upper Bound |
|-----------|----------|-------------|-------------|
| C | 68.92% | 57.10% | 79.17% |
| C+ | 68.18% | 45.13% | 86.14% |
| C | 69.23% | 54.90% | 81.28% |

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Public Health Service

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three strands intertwined, representing the three branches of government. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus.

Fujirebio Diagnostics, Inc. c/o Ms. Diana L. Wolaniuk Clinical and Regulatroy Affairs Specialist 201 Great Valley Pkwy, Malvern. PA 19355-1307

OCT 25 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k052000

Trade/Device Name: ARCHITECT® CA 19-97Mxx Assay, ARCHITECT® CA 19-9TMxR Calibrator Kit and ARCHITECT® CA 19-9™xR Control Kit Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated Antigen Immunological Test System Regulatory Class: Class II Product Code: NIG, JIT, JJX Dated: July 21, 2005 Reccived: July 27, 2005

Dear Ms. Wolaniuk:

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 as onated as 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 nate (Act) that do not require approval of a premarket approval application (PMA). You may, the (free) 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be frag 10 addy of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 complics 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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) premarket notification. The FDA finding of substantial equivalence of your device to 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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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 Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerf

Robert L. Becker, Jr., MD, P2 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): K052000

Device Name: ARCHITECT® CA 19-9 1 xR

Indications For Use:

### ARCHITECT CA 19-9xR Reagent Kit

ARCHITECT CA 19-9xe Reagent All
The ARCHITECT CA 19-9xe assay is a chemiuminescent micropaticle immunoassay (CMA)
The ARCHITECT CA 19-9xe assay is a cheminents in human serum The ARCHITECT CA 19-9x assy is a Cremination of 116-NS-19 reactive defeninents in human serum of for the quantitative determination of TTT-HRCHITECT CA 19-5x, assay is to be used as an
plasma on the ARCHITECT i System. The ARCHITECT CA 19-5x, assay is to be used as an plasma on the ARCHITECT 7 System. The Arconnellon with other clinical methods.
aid in the management of pancreatic cancer patients in councenting will be unable in aid in the management of pancreatic caliter patients in vol Janothern will be unable to
Patients known to be genotypically negative for the Lewis blood group and the Patients known to be genotypically negative of malional tissue. Phenotyping for the produce the CA 19-9 antigen may be insufficient to detect true lewis antigen negative presence of the Lewis antigen Thay be Insultient to dotson and antigen may produce
individuals. Even patients who are genolypically positive for the Lewis antigen may produc individuals: " Even patiento was on gene dosage effect.

ARCHITECT CA 19-9xR Calibrator Kit

ARCHITECT CA 19-9xe Calibrators are the calibration of the ARCHITECT i System
The ARCHITECT CA 19-9x2 Calibrators are for the calibration of 1146 NS 10 Broadiye deferminants when used for the quantitative determination of 1116-NS-199 readive deferminants in human when used for the quantitative detemmation of 1710-No 16-9 readers of the many of the many of information.

## ARCHITECT CA 19-9xR Control Kit

ARCHITECT CA 19-9xe Control All
The ARCHITECT CA 19-9xe Control Street on the estimation of the detection and the detection The ARCHITECT CA 19-9x4 Controls are for the estimation of ortent (reagents, calibrators, and of systematic analytical devations of the Artical version of 1116-NS-19-9 reactive instrument), when used for the quantitative measurement of the ARCHITECT CA 19-9xR reagent package insert for additional information.

Prescription Use V (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)

Maria Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1

510(k) K0152000