ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
Device Facts
| Record ID | K093957 |
|---|---|
| Device Name | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, |
| Applicant | Fujirebio Diagnostics,Inc. |
| Product Code | OIU · Immunology |
| Decision Date | Mar 18, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
Intended Use
The ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum. The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
Device Story
ARCHITECT HE4 assay is a two-step chemiluminescent microparticle immunoassay (CMIA) for quantitative HE4 antigen measurement in human serum. Input: patient serum sample. Process: sample combined with anti-HE4 coated paramagnetic microparticles; HE4 antigen binds; wash cycle; addition of acridinium-labeled anti-HE4 conjugate; second wash; addition of pre-trigger and trigger solutions; chemiluminescent reaction measured as relative light units (RLUs) by ARCHITECT i System optics. Output: quantitative HE4 concentration based on calibrator curve. Used in clinical/hospital laboratories by trained personnel. Output assists clinicians in monitoring disease status (recurrence/progression) in epithelial ovarian cancer patients. Benefits: provides objective serial monitoring data to support clinical decision-making alongside other diagnostic methods.
Clinical Evidence
Clinical study evaluated 76 patients with epithelial ovarian cancer (430 sequential pairs). Primary endpoint: correlation between HE4 concentration changes and disease status. A 14% increase in HE4 was defined as a positive change. Results: 54% sensitivity and 79% specificity for disease progression at the 14% threshold. Total concordance was 73%. Bench testing included method comparison (n=193, r=0.97), precision (total CV ≤ 10%), linearity (20.0–1500.0 pmol/L), and sensitivity (LoD ≤ 15 pmol/L, LoQ ≤ 20 pmol/L). Interference and cross-reactivity studies showed no significant impact from common therapeutic agents or endogenous substances.
Technological Characteristics
CMIA technology; uses mouse monoclonal antibodies (2H5 capture, 3D8 detection); paramagnetic microparticles; acridinium-labeled conjugate; chemiluminescent detection. Measurement range: 20.0–1500.0 pmol/L. Instrument: ARCHITECT i System. Standards: NCCLS/CLSI guidelines (EP5-A2, EP6-A, EP17-A, EP7-A2).
Indications for Use
Indicated for monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. For use in clinical and hospital laboratories via serial testing in conjunction with other clinical methods.
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
- HE4 EIA (K072939)
Related Devices
- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators · Fujirebio Diagnostics,Inc. · Nov 24, 2015
- K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 · Roche Diagnostics · Sep 10, 2012
- K072939 — HE4 EIA, MODEL: 404-10 US · Fujirebio Diagnostics,Inc. · Jun 9, 2008
Submission Summary (Full Text)
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### 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _K093957
#### Submitter Information
MAR 1 8 2010
- Fujirebio Diagnostics, Inc. Address: 201 Great Valley Parkway Malvern, PA 19355 Stacey Dolan Contact person: (610) 240-3843 dolans@fdi.com
Summary preparation date: December 21, 2009
Name of Device
| Trade/Proprietary Name: | ARCHITECT HE4 Assay |
|-------------------------|---------------------------|
| | ARCHITECT HE4 Calibrators |
| | ARCHITECT HE4 Controls |
- Tumor Associated Antigen Immunological Test System Common/Usual Name: Calibrator Quality control material (assayed and unassayed).
21 CFR 862.1660
Class II
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- 21 CFR 866.6010 Regulation Number: 21 CFR 862.1150
Regulatory Class:
Product Code:
JIT JX
#### Predicate Device
HE4 EIA (K072939)
### Device Description
The ARCHITECT HE4 assay is a two-step immunoassay for the quantitative determination of HE4 antigen in human serum using CMIA technology with flexible assay protocols, referred to as Chemiflex.
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In the first step, sample and 2H5 anti-HE4 coated paramagnetic microparticles are combined. HE4 antigen present in the sample binds to the anti-HE4 coated microparticles. After washing, 3D8 anti-HE4 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger 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 HE4 antigen in the sample and the RLUs detected by the ARCHITECT i System optics.
The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
#### Intended Use
#### Reagent Kit
The ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum.
The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in coniunction with other clinical methods used for monitoring ovarian cancer.
#### Calibrator Kit
The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
#### Control Kit
The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
1. For Company Company
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#### Statement of Substantial Equivalence
The ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum.
The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The ARCHITECT HE4 assay is substantially equivalent to the HE4 EIA.. Both of the devices are IVD products and are indicated for the quantitative determination of HE4 antigen in human serum as well as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The regulatory submission will be prepared pursuant to Title 21CFR § 866.6010(b) which states Tumor Markers must comply with the following special controls;
- 1. Guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA".
- 2. Voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards (NCCLS).
A comparison of the features of the ARCHITECT HE4 assay and the HE4 EIA: are as follows:
. 2014 2017 2017 2012 2012 2012
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| Similarities | | |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ARCHITECT HE4<br>(Proposed Device) | HE4 EIA<br>(Predicate Device)<br>K072939 |
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class II | Class II |
| CFR section | 866.6010 | 866.6010 |
| Product Code | OIU | OIU |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Quantitative determination of HE4<br>antigen in human serum.<br>The assay is to be used as an aid<br>in monitoring recurrence or<br>progressive disease in patients<br>with epithelial ovarian cancer.<br>Serial testing for patient HE4<br>assay values should be used in<br>conjunction with other clinical<br>methods used for monitoring<br>ovarian cancer. | Quantitative determination of HE4<br>antigen in human serum.<br>The assay is to be used as an aid<br>in monitoring recurrence or<br>progressive disease in patients<br>with epithelial ovarian cancer.<br>Serial testing for patient HE4<br>assay values should be used in<br>conjunction with other clinical<br>methods used for monitoring<br>ovarian cancer. |
| Type of Specimen | Human Serum | Human Serum |
| Specimen Collection<br>Method | Routine Phlebotomy Techniques | Routine Phlebotomy Techniques |
| Antigen Detected | HE4 | HE4 |
| Capture Antibody | Mouse monoclonal (2H5) | Mouse monoclonal (2H5) |
| Detection Antibody | Mouse monoclonal (3D8) | Mouse monoclonal (3D8) |
| Differences | | |
|---------------------------|-----------------------------------------------------|------------------------------------------|
| | ARCHITECT HE4<br>(Proposed Device) | HE4 EIA<br>(Predicate Device)<br>K072939 |
| Instrument System | ARCHITECT i System | Manual |
| Principle of Operation | Chemiluminscent Microparticle<br>Immunoassay (CMIA) | Manual Enzymatic Immunoassay<br>(EIA) |
| Calibrators | 6 Levels (0 - 1500 pmol/L) | 6 Levels (0 - 900 pM) |
| Controls | 3 Levels (50, 175 and 700 pmol/L) | 2 Levels (50 and 400pM) |
| | Supplied as separate kit | Supplied with Kit |
| Interpretation of Results | Calibrator Curve | Standard Curve |
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## Performance Characteristics
#### Method Comparison:
The ARCHITECT HE4 assay is designed to have a slope of 1.0 ± 0.1 and a correlation coefficient (r) of ≥ 0.90 for serum specimens when compared to a commercially available HE4 EIA. One hundred and ninety-three serum specimens were tested using the ARCHITECT HE4 assay and the HE4 EIA. The data are summarized in the following table.
| Regression<br>Method | n | Slope<br>(95% CIa) | Intercept<br>(95% CIa) | Correlation<br>Coefficient |
|----------------------|-----|------------------------|---------------------------|----------------------------|
| Passing-Bablokb | 193 | 0.96<br>(0.93 to 1.00) | -2.51<br>(-3.96 to -0.73) | 0.97 |
## ARCHITECT HE4 vs. HE4 EIA
ARCHITECT HE4 Specimen Range = 20.3 to 918.7 pmol/L
HE4 EIA Specimen Range = 21.9 to 762.3 pmol/L
a CI = Confidence Interval
b A linear regression method with no special assumptions regarding the distribution of the samples and measurement errors.
#### Precision:
The ARCHITECT HE4 assay is designed to have an imprecision of ≤ 10% total CV. A study was performed based on guidance from the National Committee for Clinical Laboratory standards (NCCLS) document EP5-A2. Testing was conducted at Fujirebio Diagnostics, Inc. using one lot of reagents, calibrators, and controls and at two external sites using two lots of reagents, calibrators, and controls. Three levels of controls and panels were assayed on one instrument per site in replicates of two at two separate times per day for 20 different days. Each instrument used a single calibration curve throughout the study.
#### Linearity:
The ARCHITECT HE4 assay is designed to be linear across the measurement range of 20.0 to 1500.0 pmol/L. Samples were prepared by mixing serum panels with diluted wash buffer and tested with the ARCHITECT HE4 assay. Based on a study performed by guidance from the NCCLS document EP6-A, the ARCHITECT HE4 assay demonstrated linearity from 20.0 to 1500.0 pmol/L.
#### Sensitivity (LoB, LoD, LoQ):
The ARCHITECT HE4 assay is designed to have a Limit of Detection (LoD) of ≤ 15 pmoИL and a Limit of Quantitation (LoQ) of ≤ 20 pmol/L. The LoQ is defined as the lowest amount of analyte in a sample that can be accurately quantitated with a total allowable error of ≤ 30%. A study was performed based on guidance from the NCCLS document EP17-A with one zero-level HE4 sample and four low-level HE4 samples.
The samples were tested in a minimum of five replicates once per day for three different days using three reagent lots and two instruments. The Limit of Blank (LoB) was 0.1 pmo//L, the LoD was 0.2 pmol/L, and the LoQ was 0.2 pmol/L.
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### Specificity:
The tumor markers listed below were evaluated for cross-reactivity with the ARCHITECT HE4 assay. The tumor markers were prepared with ARCHITECT HE4 Calibrator A to achieve the concentrations indicated below. Reactivities greater than 15 pmol/L HE4 (LoD) were not observed.
| Tumor Marker | Tumor Marker<br>Concentration |
|--------------------------------|-------------------------------|
| CA 125, CA 15-3, and CA 19-9 | up to 3500 U/mL |
| Carcinoembryonic Antigen (CEA) | up to 1000 uq/L |
| a-Fetoprotein (AFP) | up to 400 ug/L |
#### Interference:
The ARCHITECT HE4 assay is designed to have an individual recovery of 100 ± 15% and a mean recovery of 100 ± 10% when comparing potential interferents to the control results. The interference studies were performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP7-A2.
#### Potentially Interfering Therapeutic Agents and Endogenous Substances
Recovery studies were performed to compare sera containing the following therapeutic agents and endogenous substances at the indicated interferent concentrations with control sera. The data are summarized in the following tables.
| Therapeutic Agent | Interferent<br>Concentration | % Recovery<br>Range | Mean %<br>Recovery |
|-------------------|------------------------------|---------------------|--------------------|
| Carboplatin | 500 µg/mL | 99 - 105 | 102 |
| Cisplatin | 165 µg/mL | 97 - 98 | 98 |
| Clotrimazole | 0.3 µg/mL | 99 - 103 | 101 |
| Cyclophosphamide | 500 µg/mL | 101 - 106 | 104 |
| Dexamethasone | 10 µg/mL | 97 - 105 | 101 |
| Doxorubicin | 1.16 µg/mL | 100 - 105 | 103 |
| Leucovorin | 2.68 µg/mL | 102 - 105 | 104 |
| Melphalan | 2.8 µg/mL | 98 - 104 | 101 |
| Methotrexate | 45 µg/mL | 96 - 100 | 98 |
| Paclitaxel | 3.5 ng/mL | 101 - 102 | 102 |
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| Endogenous<br>Substance | Interferent<br>Concentration | % Recovery<br>Range | Mean %<br>Recovery |
|-------------------------|------------------------------|---------------------|--------------------|
| Bilirubin | 20 mg/dL | 92 - 103 | 98 |
| Hemoglobin | 500 mg/dL | 104 - 113 | 108 |
| Low Protein | 3 g/dL | 101 - 107 | 103 |
| High Protein | 12 g/dL | 101 - 108 | 103 |
| Triglycerides | 3000 mg/dL | 94 - 104 | 98 |
# Potentially Interfering Clinical Conditions
Six specimens positive for HAMA and six specimens positive for Rheumatoid Factor (RF) were evaluated at the indicated interferent concentration ranges. The data are summarized in the following table.
| Clinical<br>Condition | Interferent<br>Concentration Range | % Recovery<br>Range | Mean %<br>Recovery |
|-----------------------|------------------------------------|---------------------|--------------------|
| HAMA | 45 - 155 ng/mL | 91 - 108 | 102 |
| RF | 21 - 445 IU/mL | 98 - 111 | 103 |
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#### Monitoring of Disease status in Patients Diagnosed with Epithelial Ovarian Cancer
A study was performed using the ARCHITECT HE4 assay as an aid in monitoring of disease status in epithelial ovarian cancer patients by assessing changes in HE4 levels in serial serum samples from 76 patients compared to changes in disease status. A study involving a total of 430 pairs of observations was undertaken with an average number of 6.7 observations per patient. A positive change in HE4 was defined as an increase in the value that was at least 14% greater than the previous value of the test. This level of change takes into account the analytical variability of the assay. The data are summarized in the following table.
| Change in Disease State per Sequentlal Pair | | | | | |
|---------------------------------------------|-------------------|-------------|-------|--|--|
| HE4 Concentration Change | No<br>Progression | Progression | Total | | |
| less than 14% | 261 | 46 | 307 | | |
| greater than or equal to 14% | 70 | 53 | 123 | | |
| Total | 331 | 99 | 430 | | |
Fifty-four percent (54%) or 53/99 sequential pairs from patients with disease progression demonstrated an HE4 concentration increase of greater than or equal to 14%. Seventy-nine percent (79%) or 261/331 sequential pairs for patients with no disease progression demonstrated an HE4 concentration of less than 14%. The total concordance for this study was seventy-three percent (73%) or 314/430. Clinicians may wish to use other percent changes in HE4 concentration to reflect their preferences in the trade-off between sensitivity and specificity. The following table shows the resulting sensitivities and specificities of the ARCHITECT HE4 assay at various percent changes in ARCHITECT HE4 assay concentrations, together with the positive predictive values (PPV) and negative predictive values (NPV) for the population tested (99 sequential pairs from patients with disease progression and 331 sequential pairs from patients with no progression.)
| Percent (%)<br>Change in HE4 | Sensitivity a<br>(%) | Specificity b<br>(%) | PPV c<br>(%) | NPV d<br>(%) |
|------------------------------|----------------------|----------------------|--------------|--------------|
| 10 | 57 | 75 | 40 | 85 |
| 14 | 54 | 79 | 43 | 85 |
| 20 | 48 | 84 | 48 | 85 |
| 25 | 41 | 87 | 49 | 83 |
| 50 | 31 | 94 | 60 | 82 |
| 75 | 21 | 97 | 66 | 80 |
| 100 | 18 | 98 | 69 | 80 |
a Sensitivity is 100 x (number of sequential pairs with > 14% increase in HE4 concentration from patients with disease progression/total number of sequential pairs from patients with disease progression)
b Specificity is 100 x (number of sequential pairs with < 14% increase in HE4 concentration from patients without disease progression/total number of sequential pairs from patients without disease progression)
c PPV = 100 x (number of sequential pairs with > 14% increase in HE4 concentration from patients with disease progression/total number of sequential pairs > 14% increase in HE4 concentration)
d NPV = 100 x ( number of sequential pairs with < 14% increase in HE4 concentration from patients without disease progression/total number of sequential pairs < 14% increase in HE4 concentration)
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Fujirebio Diagnostics, Inc. c/o Ms. Stacey Dolan Regulatory Affairs Specialist 201 Great Valley Parkway Malvern, PA 19355
MAR 1 8 2010
Re: k093957
Trade/Device Name: ARCHITECT HE4 assay Regulation Number: 21 CFR § 866.6010 Regulation Name: Tumor-associated Antigen Immunological Test System Regulatory Class: Class II Product Code: OIU, JIT, JJX Dated: December 22, 2009 Received: December 23, 2009
Dear Ms. Dolan:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), 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
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Page 2 - Ms. Stacey Dolan
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ie M. Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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# Indications for Use
k093957 510(k) Number (if known):
Device Name: ARCHITECT HE4
Indications For Use:
### Reagent Kit
The ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum.
The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
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)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
S10K k093957
Page 1 of 1
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# Indications for Use
510(k) Number (if known):
093957
Device Name: ARCHITECT HE4
Indications for Use:
Calibrator Kit
The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
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)
Page 1 of 1
Reeve Philip
Division Sign-Off
Office of In Vitro Diagnos Device Evaluation and
510K k093957
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# Indications for Use
510(k) Number (if known):
093957
Device Name: ARCHITECT HE4
.. . . . . . . . . . . . . . . . . . . . . . . .. ....... . Indications for Use:
Control Kit
The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT / System when used for the quantitative determination of HE4 antigen in human serum.
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)
Page 1 of 1
Geena Philip
Division Sign-Off
Office of In Vitro Diagnost Device Evaluation and
510K k093957
