(39 days)
No
The device description details a chemical reaction and photometric measurement, with no mention of AI/ML in the process or performance evaluation.
No
This device is a diagnostic reagent used to measure bilirubin levels, which aids in the diagnosis and treatment of certain disorders, but it does not directly apply or transmit energy to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block." This indicates a diagnostic purpose.
No
The device is a reagent, which is a chemical substance used in a laboratory test, not a software program. The description details a chemical reaction and photometric measurement, indicating a hardware-based analytical process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of direct bilirubin in serum and plasma." Serum and plasma are biological specimens taken from the body, and the test is performed in vitro (outside the body).
- Regulatory Definition: The provided Code of Federal Regulations definition for a bilirubin test system clearly describes a device intended to measure bilirubin levels in plasma or serum, which aligns perfectly with the intended use of this device. It also states that such devices are used in the diagnosis and treatment of various disorders, which is a key characteristic of IVDs.
- Device Description: The device description details a chemical reaction performed on the sample (serum or plasma) to measure the bilirubin concentration. This is a typical process for an in vitro diagnostic test.
- Predicate Device: The predicate device listed is also a "Direct Bilirubin reagent system," further indicating that this type of device is classified as an IVD.
The fact that it's used on automated clinical chemistry analyzers and is intended for use in adults and neonates are also consistent with it being an IVD used in a clinical laboratory setting.
N/A
Intended Use / Indications for Use
The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, 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 destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Product codes
75CIG, CIG
Device Description
Direct bilirubin, in the absence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (pH 1 - 2).
Bilirubin + diazonium ion acid -> Azobilirubin
The intensity of the color of the azobilirubin formed is proportional to the direct bilirubin concentration and can be measured photometrically.
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
adults and neonates
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)
The performance of the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II reagent system, included in K790335.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
:
JUL 7 1998
ලෙස පොදුන්
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Roche Diagnostics, Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000 |
| | Contact Person: Luann Ochs |
| | Date Prepared: May 28, 1998 |
| 2) Device name | Proprietary name: Roche Diagnostics, Boehringer Mannheim Liquid Direct
Bilirubin Reagent |
| | Common name: bilirubin (total or direct) test system |
| | Classification name: Diazo colorimeter, bilirubin, 75CIG
Device Class II |
| 3) Predicate
device | We claim substantial equivalence to the currently marketed Roche Diagnostics,
Boehringer Mannheim Direct Bilirubin reagent system, catalog number
704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II
reagent system, included in K790335. |
| 4) Device
Description | Direct bilirubin, in the absence of a suitable solubilizing agent, is coupled with
a diazonium ion in a strongly acid medium (pH 1 - 2). |
| | Bilirubin + diazonium ion acid -> Azobilirubin |
| | The intensity of the color of the azobilirubin formed is proportional to the
direct bilirubin concentration and can be measured photometrically. |
Continued on next page
ﺎﺕ ﺳ
1
510(k) Summary, Continued
The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent 5) Intended use is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.
The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent 6) Comparison is substantially equivalent to other products in commercial distribution to predicate intended for similar use. Most notably it is substantially equivalent to the device currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II reagent system, included in K790335.
The following table illustrates the similarities between the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent and the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI.
| Feature | New Liquid Direct
Bilirubin Reagent | Predicate Direct
Bilirubin Reagent |
|------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of direct
bilirubin | Measurement of direct
bilirubin |
| Sample Type | Serum or plasma, no
preparation required | Serum or plasma, no
preparation required |
| Use on Automated
Chemistry Analyzers? | Yes | Yes |
| Test Principle | Diazo reaction with
formation of an
azobilirubin product,
measured
spectrophotometrically | Diazo reaction with
formation of an
azobilirubin product,
measured
spectrophotometrically |
| Calibration | Uses commercially
available calibrators
with assigned values for
direct bilirubin | Uses commercially
available calibrators
with assigned values for
direct bilirubin |
Similarities:
Continued on next page
2
510(k) Summary, Continued
| Feature | New Liquid Direct
Bilirubin Reagent | Predicate Direct
Bilirubin Reagent |
|-------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Calibration Stability | Perform a new
calibration once a week,
or with a bottle or
reagent lot change | Perform a new
calibration once daily,
or with a bottle or
reagent lot change |
| Reagent On-board
Stability | 4 weeks | 14 days |
| Kit Configuration,
Reagent Preparation | R1, liquid, ready-to-use
R2, liquid, ready-to-use | R1, liquid, ready to use
R2, combine bottles 2
(sulfanilic) and 2a
(nitrite), then add 2b
(diluent) |
- Comparison to predicate device (continued)
6) Comparison to predicate device, continued
Differences:
There are no significant differences between the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent and the predicate device for purposes of considering substantial equivalence.
Performance characteristics:
The performance of the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027, a modification of the Boehringer Mannheim / Hycel Bilirubin II reagent system, included in K790335.
3
Image /page/3/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
7 1998 JUL
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Luann Ochs Clinical Research Manager Roche Diagnostics, Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46256
Re : K981883 Liquid Direct Bilirubin Reagent Requlatory Class: II Product Code: CIG Dated: May 28, 1998 Received: May 29, 1998
Dear Ms. Ochs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ್ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.qov".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Device Name: Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent
Indications for Use:
The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, 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 destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
Division of Clinical Laboratory Devices
| 510(k) Number: | K981883 |
|---|---|
| ---------------- | --------- |