(66 days)
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No
The device description details a standard chemiluminescent immunoassay technology (LOCI™) for measuring hCG. There is no mention of AI, ML, or any computational methods beyond standard signal processing for quantitative measurement.
No
The device is described as an "in vitro diagnostic assay" and "in vitro diagnostic product" used for quantitative measurement and calibration, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the BHCG method is "an in vitro diagnostic assay."
No
The device description clearly outlines physical components (reagents, beads, antibodies, calibrator) and a chemical reaction process, indicating it is a hardware-based in vitro diagnostic assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the BHCG method and calibrator are "in vitro diagnostic assay" and "in vitro diagnostic product" respectively. It also describes their use for the "quantitative measurement of total Beta (B) human chorionic gonadotropin... in human serum and plasma," which is a biological sample.
- Method Description: The description details a laboratory-based immunoassay method (LOCI™ technology) that analyzes components within a biological sample (serum and plasma).
- Calibrator Description: The calibrator is used to calibrate the method, which is a standard practice for quantitative in vitro diagnostic tests.
- Intended User/Care Setting: The "Prescription Use" designation is common for IVDs used in a clinical laboratory setting.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DHA, JIT
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 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.
0
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
1
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.
2
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 vitro
diagnostic assay for the
quantitative measurement of total
Beta (β) human chorionic
gonadotropin: both the intact hCG
dimer and the free β subunit of
human chorionic gonadotropin
hormone in human serum and
plasma on the Dimension Vista™
system. Measurements of β human
chorionic gonadotropin are used
for the early detection of
pregnancy. | The HCG method for the
Dimension® clinical chemistry
system with the heterogeneous
immunoassay module is intended to
quantitatively measure intact human
chorionic gonadotropin in serum and
plasma for the early detection of
pregnancy. |
| Assay Type | immunoassay
(chemiluminescent) | immunoassay (photometric) |
| Sample type | Serum and plasma | Serum and plasma |
| Reportable Range | 1-1000 mIU/mL | 1-1000 mIU/mL |
| Analytical
Sensitivity | ≤ 1 mIU/mL | ≤ 1 mIU/mL |
| Sample Volume | 2 µL | 40 µL |
Calibrator:
and the comments of the comments of the province of the second
.
. .
:
:
: 上一篇: 上一篇: 上一篇:
. T
| Feature | Dimension Vista™ βhCG
Calibrator | Dimension® HCG Calibrator
(K970396) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BHCG calibrator is an in vitro diagnostic product for the
calibration of the Total Beta (β)
Human Chorionic Gonadotropin
method for the Dimension Vista™
System. | The Human Chorionic Gonadotropin
Calibrator is an in vitro diagnostic
product intended to be used to
calibrate the Human chorionic
gonadotropin (HCG Cat. No. RF430
and LHCG Cat, No. RF530) methods
for the Dimension® clinical
chemistry system with the
heterogeneous immunoassay module.
This product was designed to meet
the 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 per | |
| vial for level A, 1.0 mL per vial for | ||
| level B, C, D, E, 1.5 mL per vial for | ||
| level F | 10 vials, 2 at each level, reconstituted | |
| volume 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
4
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
6
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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