(19 days)
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No
The device description details a chemical oxidation method for measuring bilirubin, and there is no mention of AI or ML in the provided text.
No
The device is an in vitro diagnostic reagent used for the quantitative determination of serum Total Bilirubin. It is not directly applied to a patient for treatment or diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the N-ASSAY L T-BIL Reagent is for "quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases." This indicates its role in identifying and monitoring health conditions.
No
The device is a chemical reagent for in vitro diagnostic use, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Intended Use: The intended use is for the "quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases." This is a diagnostic purpose performed outside of the body (in vitro) using a biological sample (serum).
- Device Description: The description details a chemical method for analyzing a serum sample to measure a specific analyte (Total Bilirubin). This is characteristic of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The intended use for the N-ASSAY L T-BIL Reagent is for the quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.
Product codes
CIG
Device Description
The N-ASSAY L T-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar Total Bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. In this method, a serum sample containing total bilirubin is mixed with the reagent containing sodium nitrite. Total bilirubin (direct bilirubin) is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the total billinubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.
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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In comparison studies against the predicate assay, a correlation coefficient of 0.99922 and a regression equation y = 1.0166 x + 0.1192 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 0.05 mg/dl. The N-ASSAY L T-BIL reagent is linear to 50 mg/dl.
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
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§ 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
CRESTAT DIAGNOSTICS, INC.
25549 Adams Avenue Murrieta, CA 92562
1300/HAGG
APR 2 7 1998
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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.
The assigned 510(k) number is:
Date:
April 2, 1998
Colin Getty Submitted by: KAMIYA BİOMEDICAL COMPANY 910 Industry Drive, Seattle WA 98188 TEL: 206-575-8068; FAX: 206-575-8094
For:
Murrieta, CA 92562
N-ASSAY L T-BIL (Total Bilirubin Assay Reagent) Product:
Crestat Diagnostics, Inc.
25549 Adams Avenue
Serum bilirubin measurement is widely used as a screening test for liver functions. The diazo coupling method and bilirubin oxidase enzymatic method are widely used; however, these methods have disadvantages such as interference by coexistent serum substances and poor reagent stability.
The N-ASSAY L T-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar Total Bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.
In this method, a serum sample containing total bilirubin is mixed with the reagent containing sodium nitrite. Total bilirubin (direct bilirubin) is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the total billinubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.
1
CRESTAT DIAGNOSTICS, INC.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
The safety and effectiveness of the liquid Crestat N-ASSAY L T-BIL Reagent is demonstrated by its substantial equivalence to the WAKO Chemicals Total Bilirubin liquid reagent (K970985) which is also based on chemical oxidation. Both test systems are intended to quantitatively measure Total Bilirubin in human serum.
In comparison studies against the predicate assay, a correlation coefficient of 0.99922 and a regression equation y = 1.0166 x + 0.1192 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 0.05 mg/dl. The N-ASSAY L T-BIL reagent is linear to 50 mg/dl.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure with three heads in profile, facing to the right. The figure is composed of flowing lines, creating a sense of movement and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 27 1998
Crestat Diagnostics, Inc. Colin Getty C/O KAMIYA Biomedical Company 910 Industry Drive Seattle, Washington 98188
K981289 Re: N-ASSAY L T-BIL (Total Bilirubin Assay Reagent) Requlatory Class: II Product Code: CIG Dated: April 2, 1998 Received: April 8, 1998
Dear Mr. Getty:
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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 .
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 Other general 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 "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
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
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _
N-ASSAY L T-BIL (Total Bilirubin Assay Reagent) Device Name:
Indications For Use:
The intended use for the N-ASSAY L T-BIL Reagent is for the quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981289
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _
Optional Format 1-2-96)
OR