(61 days)
Not Found
No
The device description details a chemical reaction and spectrophotometric measurement, with no mention of AI or ML algorithms.
No
This device is an in vitro diagnostic test used for the quantitative measurement of direct bilirubin, which aids in the diagnosis and treatment of various disorders but does not directly treat or provide therapy to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The DBIL method is an in vitro diagnostic test" and that measurements are "used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders."
No
The device is an in vitro diagnostic test that measures direct bilirubin in human serum and plasma using chemical reactions and optical measurements on a specific hardware system (Dimension Vista™ System). This involves physical reagents and hardware components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states, "The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma..." This directly identifies it as an IVD.
- Device Description: The description details a chemical reaction performed on a human sample (serum and plasma) to measure a substance (bilirubin) for diagnostic purposes. This is characteristic of an in vitro diagnostic test.
- Purpose: The intended use clearly states that the measurements are used "in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders..." This confirms its role in diagnosing medical conditions.
N/A
Intended Use / Indications for Use
The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.
Product codes (comma separated list FDA assigned to the subject device)
CIG
Device Description
Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. The sample is diluted in 0.5M HCl. A blank reading is taken to eliminate interference from nonbilirubin pigments. Upon addition of the diazotized sulfanilic acid, the conjugated bilirubin is converted to diazo-bilirubin, a red chromophore which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique.
Conjugated bilirubin + Diazotized sulfanilic acid ----------------------------------------------------------------------------------------------------------------------------
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Testing results demonstrate that the Dimension Vista™ DBIL Flex® reagent cartridge is equivalent to the predicate device. Method comparison results provided a slope of 0.97, intercept of 0.01 mg/dL and correlation of 0.999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 0.05 mg/dL
Repeatability: 9.1%CV @ 0.4 mg/dL; 2.1%CV @ 5.9 mg/dL
Reference Interval:
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
AUG 2 9 2006
510(k) Summarv
Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "KO61839". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The sequence consists of two uppercase letters, "K" and "O", followed by the numbers 6, 1, 8, 3, and 9.
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.
| Submitter's Name: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101
302-631-9798
302-631-6299 (fax) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | June 28, 2006 |
| Name of Products: | DBIL Flex® reagent cartridge |
| FDA Classification Name: | Bilirubin (total or direct) test system |
| Predicate Device: | Dade Behring DBIL Flex® reagent cartridge (K862359) |
Device Description:
Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. The sample is diluted in 0.5M HCl. A blank reading is taken to eliminate interference from nonbilirubin pigments. Upon addition of the diazotized sulfanilic acid, the conjugated bilirubin is converted to diazo-bilirubin, a red chromophore which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique.
Conjugated bilirubin + Diazotized sulfanilic acid ----------------------------------------------------------------------------------------------------------------------------
Intended Use:
The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.
Comparison to the predicate device:
The DBIL Flex® reagent cartridge is substantially equivalent in intended use, principle and performance to the predicate Dade Behring DBIL assay, K862359. The assay is an in vitro assay with intended use for the measurement of direct bilirubin in human serum and plasma.
A summary of the features of the predicate and the Dimension Vista™ DBIL Flex® reagent cartridge assay is provided in the following chart. Although the intended use statement has been
1
modified for the test assay to align with CFR 862.1110, there are no different claims for the test assay.
| Attribute | Dimension® DBIL
Assay (K862359) | Dimension Vista™ DBIL |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DBIL method used
on the Dimension®
clinical chemistry
system is an in vitro
diagnostic test intended
for the quantitative
determination of direct
(conjugated) bilirubin in
serum and plasma. | The DBIL method is an in vitro
diagnostic test for the quantitative
measurement of direct (conjugated)
bilirubin in human serum and plasma
on the Dimension Vista™ System.
Measurements of direct bilirubin are
used in the diagnosis and treatment
of liver, hemolytic, hematological
and metabolic disorders, including
hepatitis and gall bladder disease. |
| Sample type | Human serum and
plasma | Human serum and plasma |
| Methodology | Photometric (diazo
chemistry) | Photometric (diazo chemistry) |
| Detection | Bichromatic (540, 700
nm) | Bichromatic (540, 700 nm) |
| Sample volume | 31 uL | 5 uL |
| Hemoglobin Flag | Yes | Yes |
| Analytical
Sensitivity | Not provided | 0.05 mg/dL |
| Repeatability | 4.7 %CV at 5 mg/dL | 9.1%CV @ 0.4 mg/dL
2.1%CV @ 5.9 mg/dL |
| Reference
Interval | George M. Plummer Quality Assurance and Compliance Manager Date: June 28, 2006
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 9 2006
Mr. George M. Plummer Dade Behring, Inc. P.O. Box 6101, Mailstop 514 Newark, DE 19714
Re: K061839
Trade/Device Name: DBIL Flex® reagent cartridge Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: June 28, 2006 Received: June 29, 2006
Dear Mr. Plummer
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).
3
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) 276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
5 10(k) Number (if known):
Kd6/839
Device Name:
DBIL Flex® reagent cartridge
Indications for Use:
The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.
Prescription Use X (Per 21 CRF 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)
Carol Benson
Livision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety