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.

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.

AI/ML Overview

Acceptance Criteria and Study for Crestat N-ASSAY L T-BIL Reagent

This medical device is a diagnostic reagent for measuring total bilirubin. The provided text describes a 510(k) submission, focusing on establishing substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values in the format of a typical performance goal. Instead, the study aims to demonstrate substantial equivalence to a predicate device. The performance metrics reported are for comparison to this predicate.

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Correlation Coefficient (vs. Predicate)	High correlation (e.g., >0.95 or >0.98)	0.99922
Regression Equation (vs. Predicate)	Close to y = x (slope ~1, intercept ~0)	y = 1.0166 x + 0.1192
Precision	Acceptable (qualitative statement)	"acceptable values can be obtained on a day to day basis"
Minimum Detectable Level	Comparable to predicate / clinically acceptable	0.05 mg/dl
Linearity	Comparable to predicate / clinically acceptable	Linear to 50 mg/dl
Interference by Coexistent Substances	Practically no interference	"practically no interference by coexistent substances"
Reproducibility	Good reproducibility	"good reproducibility"
Sensitivity	High sensitivity	"high sensitivity"
Assay Range	Wide assay range	"wide assay range"

Note: The "acceptance criteria" are inferred based on demonstrating substantial equivalence, meaning the performance should be very similar to or better than the predicate's known performance.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The text mentions "serum samples" were used in comparison studies against the predicate.
Data Provenance: Not explicitly stated. Given it's a 510(k) from 1998 in the US, it's highly likely the data was collected in the US. It's also typical for such studies to be prospective, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this type of in vitro diagnostic device is typically established against a reference method or by comparison to a legally marketed predicate device, rather than expert consensus on individual cases.

4. Adjudication Method

Not applicable. No expert adjudication method is described as the study focuses on quantitative measurement and comparison to a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic (IVD) reagent, and MRMC studies are typically performed for imaging or qualitative diagnostic devices where human interpretation is a key component. The effectiveness study here is based on quantitative analytical performance against a predicate.

6. Standalone Performance Study

Yes, the analytical performance (correlation coefficient, regression equation, precision, minimum detectable level, linearity, interference, reproducibility, sensitivity, assay range) of the N-ASSAY L T-BIL reagent was evaluated on its own and compared to the predicate device. This constitutes a standalone performance evaluation in the context of IVD reagents.

7. Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device, specifically the WAKO Chemicals Total Bilirubin liquid reagent (K970985). This predicate device serves as the "reference standard" against which the new device's performance is measured to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is an analytical device for measuring a biochemical marker. There is no "training set" in the machine learning sense. The device's performance is determined by its chemical reagents and reaction principles, which are developed through R&D, not by training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied for this type of device.

Summary

{0}------------------------------------------------

K981289

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.

{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 .

{3}------------------------------------------------

Page 2

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:

(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)

Regulation Number and Section

§ 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.