(38 days)
No
The device description details a chemical reaction and photometric measurement, with no mention of AI or ML. The performance studies compare the reagent's performance to existing chemical reagent systems.
No
The device is a reagent intended for in vitro diagnostic use to measure total bilirubin levels, which assists in diagnosis and treatment, but does not directly provide therapy.
Yes
The device quantitatively determines total bilirubin, and according to the Code of Federal Regulations, bilirubin level measurements are "used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders."
No
The device description clearly outlines a chemical reagent and its reaction, which is a physical substance, not software. The device is intended for use on automated clinical chemistry analyzers, which are hardware devices.
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 total bilirubin in serum and plasma of adults and neonates." This involves testing biological samples (serum and plasma) outside of the body.
- Regulatory Definition: The document references the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, which defines a bilirubin test system as a device intended to measure bilirubin levels in plasma or serum. This aligns perfectly with the device's purpose.
- Purpose in Diagnosis and Treatment: The regulatory definition also states that measurements of bilirubin levels are used in the "diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders." This confirms the diagnostic nature of the test.
- Device Description: The description details a chemical reaction that occurs with the sample (serum or plasma) to produce a measurable result (color intensity). This is characteristic of an in vitro diagnostic test.
Therefore, based on its intended use, the regulatory definition provided, and the description of how it functions, the Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total 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 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.
Product codes
CIG, MQM
Device Description
Total bilirubin, in the presence 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 total 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
automated clinical chemistry analyzers
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 Total 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 Total Bilirubin/DPD reagent system, catalog number 1039034, a modification of the Single Vial DPD Total Bilirubin reagent system, K781921.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and consists of a stylized eagle. The U.S. Food & Drug Administration logo is on the right and consists of the FDA acronym in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 14, 2019
Roche Diagnostics/Boehringer Mannheim Gmbh Luann Ochs 9115 Hague Rd. Indianapolis, IN 46256
Re: K981632
Trade/Device Name: Liquid Total Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, MQM Dated: May 7, 1998 Received: May 8, 1998
Dear Luann Ochs:
This letter corrects our substantially equivalent letter of June 15, 1998.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): Device Name: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent
Indications for Use:
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total 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 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.
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 Sign-Off)
Division of Clinical Laboratory Zevices
510(k) Number K981633
3
JUN 1 5 1998
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 7, 1998 |
| 2) Device name | Proprietary name: Roche Diagnostics, Boehringer Mannheim Liquid Total
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 Total Bilirubin/DPD reagent system, catalog number
1039034, a modification of the Single Vial DPD Total Bilirubin reagent
system, K781921. |
| 4) Device
Description | Total bilirubin, in the presence 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 total
bilirubin concentration and can be measured photometrically. |
Continued on next page
4
510(k) Summary, Continued
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent 5) Intended use is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.
The Roche Diagnostics, Boehringer Mannheim Liquid Total 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 Total Bilirubin/DPD reagent system, catalog number 1039034, a modification of the Single Vial DPD Total Bilirubin reagent system, K781921.
The following table illustrates the similarities between the Roche Diagnostics, Boehringer Mannheim Liquid Total 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 Total
Bilirubin Reagent | Predicate Total
Bilirubin Reagent |
|------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of total
bilirubin | Measurement of total
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 | Two points, blank
(saline) and about 2.6
mg/dL total bilirubin | Two points, blank
(saline) and about 2.6
mg/dL total bilirubin |
Similarities:
Continued on next page
5
510(k) Summary, Continued
| Feature | New Liquid Total
Bilirubin Reagent | Predicate Total
Bilirubin Reagent |
|-------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Calibration Stability | Perform a new
calibration once a week,
or with a bottle or
reagent lot change | Perform a new
calibration once a week,
or with a bottle or
reagent lot change |
| Reagent On-board
Stability | 5 weeks | 5 days |
| Kit Configuration,
Reagent Preparation | R1, liquid, ready-to-use
R2, liquid, ready-to-use | R1a, lyophilized,
requires reconstitution
with buffer
R1, buffer |
- Comparison to predicate device (continued)
6) Comparison Differences: to predicate device, continued
There are no significant differences between the Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent and the predicate device for purposes of considering substantial equivalence.
Performance characteristics:
The performance of the Roche Diagnostics, Boehringer Mannheim Liquid Total 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 Total Bilirubin/DPD reagent system, catalog number 1039034, a modification of the Single Vial DPD Total Bilirubin reagent system, K781921.