(66 days)
Method: The BHCG method is an in vitro diagnostic assay for the quantitative measurement of total Beta (B) human chorionic gonadotropin: both the intact hCG dimer and the free ß subunit of human chorionic gonadotropin hormone in human serum and plasma on the Dimension Vista™ system. Measurements of B human chorionic gonadotropin are used for the early detection of pregnancy.
Calibrator: The BHCG calibrator is an in vitro diagnostic product for the calibration of the Total Beta (B) Human Chorionic Gonadotropin (BHCG) method for the Dimension Vista™ System.
Method: The BHCG method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCTM reagents include two synthetic bead reagents and a biotinylated anti-ShCG monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ShCG monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a bead-BhCG-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the nicked and non-nicked free, and nicked and non-nicked intact ß human chorionic gonadotropin concentration in the sample.
Calibrator: The BHCG Calibrator is a liquid product containing human chorionic gonadotropin in a bovine calf serum matrix with stabilizers and preservative. The kit consists of twelve vials, two each of six levels containing 2.0 mL per vial for level A. 1.0 mL per vial for levels B. C. D. and E, 1.5 mL per vial for level F. Description of the manufacturing, value assignment and stability testing processes are provided.
The Dade Behring Dimension Vista™ BHCG method is an in vitro diagnostic assay used for the quantitative measurement of total Beta (B) human chorionic gonadotropin in human serum and plasma for the early detection of pregnancy. The associated calibrator is for the calibration of this method.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state "acceptance criteria" in a separate section with specific numerical targets. Instead, it compares the performance characteristics of the new device (Dimension Vista™ BHCG) to a legally marketed predicate device (Dimension® Human Chorionic Gonadotropin (HCG) method, K970387). The implication is that meeting or performing comparably to the predicate device in key analytical characteristics constitutes meeting "acceptance criteria" for substantial equivalence.
| Feature | Predicate Device (Dimension® HCG) Expected Performance (Implicit Acceptance Criteria) | Dimension Vista™ BHCG Reported Performance | Outcome |
|---|---|---|---|
| Intended Use | Quantitative measurement of intact human chorionic gonadotropin in serum and plasma for early detection of pregnancy. | Quantitative measurement of total Beta (B) human chorionic gonadotropin (intact hCG dimer and free ß subunit) in human serum and plasma for early detection of pregnancy. | Functionally similar, broader analyte measurement for new device. |
| Assay Type | Immunoassay (photometric) | Immunoassay (chemiluminescent) | Different technology, but same assay principle. |
| Sample Type | Serum and plasma | Serum and plasma | Same |
| Reportable Range | 1-1000 mIU/mL | 1-1000 mIU/mL | Same |
| Analytical Sensitivity | ≤ 1 mIU/mL | ≤ 1 mIU/mL | Same |
| Sample Volume | 40 µL | 2 µL | New device uses significantly less sample. |
Calibrator Comparison:
| Feature | Predicate Device (Dimension® HCG Calibrator) Expected Performance (Implicit Acceptance Criteria) | Dimension Vista™ βhCG Calibrator Reported Performance | Outcome |
|---|---|---|---|
| Intended Use | Calibration of HCG methods for Dimension® clinical chemistry system. | Calibration of Total Beta (β) Human Chorionic Gonadotropin method for Dimension Vista™ System. | Similar, specific to respective systems. |
| Analyte | Human urine chorionic gonadotropin | Human urine chorionic gonadotropin | Same |
| Matrix | Equine serum | Bovine calf serum | Different, but both biological matrices. |
| Form | Lyophilized, reconstituted | Liquid | Different form |
| Volume | 10 vials, 2 at each level, 2 mL reconstituted volume. | 12 vials, 2 at each level, varying volumes. | Different packaging/volumes |
| Levels | 5 levels (0, 25, 155, 522, 1120 mIU/mL) | 6 levels (0, 14, 28, 160, 550, 1100 mIU/mL) | Different range and number of levels. |
Study Proving Acceptance Criteria (Substantial Equivalence):
The device meets acceptance criteria by demonstrating substantial equivalence to the predicate device. The submission states: "mousurement of haman versin and plasma samples demonstrate good analytical and clinical agreement between the methods." This implies that studies were conducted to compare the performance of the new device against the predicate. However, specific details about these studies (e.g., number of samples, study design, statistical analysis) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states "measurement of human serum and plasma samples" were used. However, it does not provide specific sample sizes for any test set or details regarding the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This section is not applicable as the document describes an in vitro diagnostic assay for quantitative measurement, not an AI or imaging device requiring expert interpretation for ground truth. The "ground truth" for quantitative assays is typically established by reference methods or validated higher-order methods, not expert consensus.
4. Adjudication Method for the Test Set:
This is not applicable for a quantitative IVD assay as described. Adjudication typically refers to resolving discrepancies between multiple expert readers, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the document describes an in vitro diagnostic reagent and calibrator, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This description is for a standalone in vitro diagnostic test system. The performance characteristics (reportable range, analytical sensitivity) are inherent to the assay itself. The comparison to the predicate device effectively serves as a standalone performance assessment relative to an established standard.
7. The Type of Ground Truth Used:
For this type of quantitative in vitro diagnostic device, the "ground truth" for comparison to a predicate device is generally established by:
- Reference Methods: Highly accurate and precise methods used to determine the true concentration of the analyte (hCG in this case).
- Validated Predicate Device Performance: The performance of the legally marketed predicate device itself, which has already been deemed safe and effective, serves as a benchmark for comparison.
The document states, "measurement of human serum and plasma samples demonstrate good analytical and clinical agreement between the methods," implying that comparisons were made to gold standard reference measurements or the established values from the predicate device.
8. The Sample Size for the Training Set:
The document does not provide specific details on any "training set" sample size. For an IVD assay like this, development typically involves method optimization and validation studies, rather than a distinct "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
As there is no explicit mention of a "training set" in the machine learning sense, the method of establishing its "ground truth" is not detailed in this summary. The process for developing such assays involves rigorous analytical validation, precision studies, linearity studies, interference studies, and accuracy studies against reference methods or the predicate, rather than a "ground truth" for a training set.
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FEB 2 3 2007
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
063754
Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation 1.
Manufacturer:
P.O. Box 6101 Newark, DE 19714
Dade Behring Inc.
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Pamela A. Jurga Tel: 302-631-8891
Date of Preparation:
December 15, 2006
2. Device Name / Classification
- . Dimension Vista™ BHCG reagent cartridge/ Class II
- . Dimension Vista™ BHCG calibrator/ Class II
3. Identification of the Predicate Device
FDA Guidance Document(s):
- "Bundling Multiple Devices or Multiple Indications in a Single Submission"-. 11/26/2003
- . "Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) in Vitro Diagnostic Devices (IVDs)" 11/06/96
4. Device Description(s):
Method
The BHCG method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCTM reagents include two synthetic bead reagents and a biotinylated anti-ShCG monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and
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contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ShCG monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a bead-BhCG-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the nicked and non-nicked free, and nicked and non-nicked intact ß human chorionic gonadotropin concentration in the sample.
Calibrator
The BHCG Calibrator is a liquid product containing human chorionic gonadotropin in a bovine calf serum matrix with stabilizers and preservative. The kit consists of twelve vials, two each of six levels containing 2.0 mL per vial for level A. 1.0 mL per vial for levels B. C. D. and E, 1.5 mL per vial for level F. Description of the manufacturing, value assignment and stability testing processes are provided.
5. Device Intended Use:
Method
The BHCG method is an in vitro diagnostic assay for the quantitative measurement of total Beta (B) human chorionic gonadotropin: both the intact hCG dimer and the free ß subunit of human chorionic gonadotropin hormone in human serum and plasma on the Dimension Vista™ system. Measurements of ( ) human chorionic gonadotropin are used for the early detection of pregnancy.
Calibrator
The BHCG calibrator is an in vitro diagnostic product for the calibration of the Total Beta (B) Human Chorionic Gonadotropin (BHCG) method for the Dimension Vista™ System.
Medical device to which equivalence is claimed: 6.
Substantial Equivalence:
These products are substantially equivalent to other HCG test systems, such as the Dimension® Human Chorionic Gonadotropin (HCG) method and calibrator. (K970387/K970396).
Comparison to Predicate Device:
The proposed Dade Behring Dimension Vista™ BHCG method and the predicate Dade Behring Dimension® Human Chorionic Gonadotropin (HCG) method are both in vitro diagnostic immunoassays intended for the measurement of human chorionic gonadotropin hormone in human serum and plasma.
The Dade Behring Dimension Vista™ BHCG calibrator and the predicate Dade Behring Dimension® Human Chorionic Gonadotropin (HCG) calibrator are both calibrators intended to calibrate their associated HCG methods.
A comparison summary of the features of the products is included in the table on the following page.
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Dade Benring Inc. Dace Bearing more
Dimension Vista™ BHCG Method and Calibrator 510(k) Premarket Notification
| Feature | Dimension Vista™ BHCG | Dimension® HCG(K970387) |
|---|---|---|
| Intended Use | The BHCG method is an in vitrodiagnostic assay for thequantitative measurement of totalBeta (β) human chorionicgonadotropin: both the intact hCGdimer and the free β subunit ofhuman chorionic gonadotropinhormone in human serum andplasma on the Dimension Vista™system. Measurements of β humanchorionic gonadotropin are usedfor the early detection ofpregnancy. | The HCG method for theDimension® clinical chemistrysystem with the heterogeneousimmunoassay module is intended toquantitatively measure intact humanchorionic gonadotropin in serum andplasma for the early detection ofpregnancy. |
| Assay Type | immunoassay(chemiluminescent) | immunoassay (photometric) |
| Sample type | Serum and plasma | Serum and plasma |
| Reportable Range | 1-1000 mIU/mL | 1-1000 mIU/mL |
| AnalyticalSensitivity | ≤ 1 mIU/mL | ≤ 1 mIU/mL |
| Sample Volume | 2 µL | 40 µL |
Calibrator:
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| Feature | Dimension Vista™ βhCGCalibrator | Dimension® HCG Calibrator(K970396) |
|---|---|---|
| Intended Use | The BHCG calibrator is an in vitro diagnostic product for thecalibration of the Total Beta (β)Human Chorionic Gonadotropinmethod for the Dimension Vista™System. | The Human Chorionic GonadotropinCalibrator is an in vitro diagnosticproduct intended to be used tocalibrate the Human chorionicgonadotropin (HCG Cat. No. RF430and LHCG Cat, No. RF530) methodsfor the Dimension® clinicalchemistry system with theheterogeneous immunoassay module.This product was designed to meetthe needs of users to assure accurate results over the assay range of this |
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| method. | ||
|---|---|---|
| Human urine chorionic gonadotropin | Human urine chorionic gonadotropin | |
| Analyte | Bovine calf serum | Equine serum |
| Matrix | Liquid | Lyophilized |
| Form | 12 vials, 2 at each level, 2.0 mL pervial for level A, 1.0 mL per vial forlevel B, C, D, E, 1.5 mL per vial forlevel F | 10 vials, 2 at each level, reconstitutedvolume 2 mL for each level |
| Volume | 6 levels (0, 14, 28, 160, 550, 1100 mIU/mL) | 5 levels (0, 25, 155, 522, 1120 mIU/mL) |
| Levels |
Comments on Substantial Equivalence:
Method
The Dade Behring Dimension Vista™ BHCG method and the Dade Behring Dimension® Human The Date Delining Dimisibler I wethod are both in vitro diagnostic immunoassays intended for the measurement of human chorionic gonadotropin hormone in human serum and plasma. mousurement of haman versin and plasma samples demonstrate good analytical and clinical agreement between the methods.
Calibrator
The Dade Behring Dimension Vista™ BHCG calibrator is similar to other calibrator products associated The Dade Belling Dimension® Human Chorion® Human Chorionic Gonadotropin (HCG) calibrator.
Conclusion:
The Dade Behring Dimension Vista™ BHCG method and the predicate Dade Behring Dimension® Human Chorionic Gonadoropin (HCG) method (K970387) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products are also substantially equivalent in its design and intended use with their respective assay systems (K970396).
Arnaldo O.
Pamela A. Jurga Regulatory Affairs and Compliance Manager December 15, 2006
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized emblem with three curved lines resembling a person with outstretched arms. The emblem is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 3 2007
Pamela A Jurga Dade Behring, Inc. P.O. Box 6101 Bldg. 500; M.S.514 Newark, DE 19714-6101
Re: K063754
Trade/Device Name: Dimension® Vista™ BHCG Flex® reagent cartridge and Dimension® Vista™ BHCG calibrator Regulation Number: 21 CFR § 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, JIT Dated: December 15, 2006 Received: December 19, 2006
Dear Ms. Jurga:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology 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):
Device Name:
- Dimension® Vista™ BHCG Flex® reagent cartridge method �
- Dimension® Vista™ BHCG calibrator
Indications For Use:
Method
The BHCG method is an in vitro diagnostic assay for the quantitative measurement of total Beta (B) human chorionic gonadotropin: both the intact hCG dimer and the free ß subunit of human chorionic gonadotropin hormone in human serum and plasma on the Dimension VistaTM system. Measurements of B human chorionic gonadotropin are used for the early detection of pregnancy.
Calibrator
The BHCG calibrator is an in vitro diagnostic product for the calibration of the Beta Human Chorionic Gonadotropin method for the Dimension Vista™ System.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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ion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.