Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems. Measurements of total bilirubin in serum and plasma are used in the diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders, such as jaundice, biliary obstruction, hepatitis and cirrhosis.

Device Description

The Dri-STAT® Enzymatic Bilirubin Reagent may be used in conjunction with the SYNCHRON® Systems Bilirubin Calibrator on the family of SYNCHRON® Systems. The reagent kit contains two reagent bottles that are transferred into a Beckman Coulter User-Defined Cartridge.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the performance characteristics demonstrated to be substantially equivalent to the predicate device. The document states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. A finding of substantial equivalence is demonstrated through method comparison, linearity, and imprecision experiments."

Therefore, the performance data presented from these experiments serve as the basis for demonstrating that the device meets the "acceptance criteria" of being substantially equivalent.

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Dri-STAT® TBE Reagent on Synchron Systems)
Method Comparison	Strong correlation with predicate method	Slope: 1.031 (on Synchron LX), 1.004 (on Synchron CX) Intercept: 0.016 (on Synchron LX), 0.004 (on Synchron CX) R: 0.9997 (on both systems)
Linearity	Not explicitly stated, but implied by method comparison and analytical range.	Not explicitly detailed in the provided text.
Imprecision (Within-Run)	Low variability; acceptable %C.V. for clinical use	Serum Control 1: 0.7 mg/dL, 0.03 S.D., 4.8 %C.V. (N=80) Serum Control 2: 4.0 mg/dL, 0.05 S.D., 1.1 %C.V. (N=80) Serum Control 3: 7.3 mg/dL, 0.08 S.D., 1.1 %C.V. (N=80) Human Pool: 19.7 mg/dL, 0.12 S.D., 0.6 %C.V. (N=80)
Imprecision (Total)	Low variability; acceptable %C.V. for clinical use	Serum Control 1: 0.7 mg/dL, 0.03 S.D., 4.8 %C.V. (N=80) Serum Control 2: 4.0 mg/dL, 0.06 S.D., 1.4 %C.V. (N=80) Serum Control 3: 7.3 mg/dL, 0.11 S.D., 1.5 %C.V. (N=80) Human Pool: 19.7 mg/dL, 0.47 S.D., 2.4 %C.V. (N=80)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- For the method comparison studies, the sample size was 70 for both the Synchron LX System and the Synchron CX System.
- For the imprecision studies, the sample size was 80 for each of the four samples (Serum Control 1, Serum Control 2, Serum Control 3, Human Pool) in both within-run and total imprecision measurements.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "Human Pool" samples, implying clinical samples were used, but further details are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For in vitro diagnostic devices like the Dri-STAT® Enzymatic Bilirubin Reagent, ground truth is typically established through reference methods or highly accurate comparative assays, not through expert consensus on qualitative interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used when subjective interpretations are involved, such as in image analysis or clinical diagnosis. For a quantitative chemical assay, the comparison is to a reference method or a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation of results, especially in fields like radiology or pathology. The Dri-STAT® Enzymatic Bilirubin Reagent is a fully automated in vitro diagnostic assay, where human intervention is minimal in the measurement process itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (method comparison, linearity, imprecision) represents the standalone performance of the Dri-STAT® Enzymatic Bilirubin Reagent on the SYNCHRON® Systems. As an automated in vitro diagnostic test, the "algorithm only" performance is the core functionality being evaluated without human interpretation of the measurement output (beyond reading the numerical result).

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this context is established by the predicate device (Dri-STAT® Enzymatic Bilirubin Reagent on Cobas Fara) for the method comparison study. For imprecision, it's about the consistency of the assay itself. The comparison to the predicate device demonstrates that the new device measures bilirubin in a substantially equivalent manner, implying its results are "true" in relation to a well-established method.

8. The Sample Size for the Training Set

This document does not mention a training set. For classical in vitro diagnostic reagents like this one, there isn't typically a "training set" in the machine learning sense. The assay is developed and validated, and then its performance is characterized using test samples.

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

As no training set is mentioned or applicable in the provided context, this information is not available.

Summary

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DEC 16 2005

Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090

510(k) Summary Dri-STAT® Enzymatic Bilirubin Reagent

1.0 Submitted By:

Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: (714) 961-4389 FAX: (714) 961-4234

2.0 Date Submitted:

November 1, 2005

3.0 Device Name(s):

3.1 Proprietary Names

Dri-STAT® Enzymatic Bilirubin Reagent SYNCHRON® Systems Bilirubin Calibrator

3.2 Classification Name

Bilirubin (total or direct) test system (21 CFR § 862.1110) Calibrator (21 CFR § 862.1150)

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
Dri-STAT®Enzymatic BilirubinReagent	Dri-STAT®Enzymatic BilirubinReagent	BeckmanCoulter, Inc. *	K843174
SYNCHRON®Systems BilirubinCalibrator	SYNCHRON®Systems BilirubinCalibrator	BeckmanCoulter, Inc.*	K791141

*Beckman Coulter, Inc., Brea, CA

SSE1

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Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090

Description: 5.0

The Dri-STAT® Enzymatic Bilirubin Reagent Enzymatic Bilirubin may be used The Dir-OTAT® Enzymation Billians in conjunction with the SYNCHRON® on the family of Oynomen Cystom ragent kit contains two reagent bottles that Systems Billirabili CallBraterferred into a Beckman Coulter User-Define Cartridge

Intended Use: 6.0

Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic Systems Billirubin Sullirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

	Similarities
TBEReagent	Intended Use	Same as Beckman Coulter
	Methodology	Dri-STAT® Enzymatic BilirubinReagent,Enzymatic Bilirubin on Cobas Fara
	Reactive Ingredients
	Sample Types
	Shelf Life
	Reaction Type
	Calibrator
	Differences
	Instrument Platforms	SYNCHRON® SystemsVsCobas Fara
	Analytical Range	Up through 35 mg/dL on predicate0.2-25 mg/dL on candidate
	Reference Intervals	0.1-1.0 mg/dL on predicate0.3-1.2 mg/dL per literature
	Wavelength	465 nm on predicate470 and 520 nm on candidate
	Reaction Volumes	0.05; 1.00; 0.08 mL on predicate10; 200; 16 µL on candidate

SSE2

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Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in moung of Substantial oquivalence is demonstrated through method comparison, linearity, and imprecision experiments.

CandidateMethod	SampleType	Slope	Inter-cept	R	n	Predicate Method
Dri-STATTBE ReagentOn SynchronLX System	Serum	1.031	0.016	0.9997	70	Beckman CoulterDri-STATEnzymatic Bilirubinon Cobas Fara
Dri-STATTBE ReagentOn SynchronCX System	Serum	1.004	0.004	0.9997	70	Beckman CoulterDri-STATEnzymatic Bilirubinon Cobas Fara

Dri-STAT Enzymatic Bilirubin Method Comparison Study Results__________________________________________________________________________________________________________________

Dri-STAT Enzymatic Bilirubin Estimated Imprecision

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Serum Control 1	0.7	0.03	4.8	80
Serum Control 2	4.0	0.05	1.1	80
Serum Control 3	7.3	0.08	1.1	80
Human Pool	19.7	0.12	0.6	80
Total Imprecision
Serum Control 1	0.7	0.03	4.8	80
Serum Control 2	4.0	0.06	1.4	80
Serum Control 3	7.3	0.11	1.5	80
Human Pool	19.7	0.47	2.4	80

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

SSE3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 16 2005

Ms. Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. Brea, CA 92822

K053090 Re:

Trade/Device Name: Dri- STAT® Enzymatic Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: JFM Dated: November 1, 2005 Received: November 2, 2005

Dear Ms. Hirumi:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to 10gm) the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costiletter (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, there's or visions of the Act include requirements for annual registration, listing of general controle profice, 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 that I Dri has intact a and regulations administered by other Federal agencies. You must or any I cutral statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing pactice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally promation in the 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 you coons 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 Four may 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 Gutz

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

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Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090

Indications for Use

510(k) Number (if known): K053090

Device Name: Dri-STAT® Enzymatic Bilirubin Reagent

Indications For Use:

Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Dri-STAT Enzymatic Billrabili Reagend, in the in vitro diagnostic Systemination of total bilirubin in human serum and plasma as a User Defined determination on SYNCHRON® Systems.

Measurements of total bilirubin in serum and plasma are used in the diagnosis Measurements of total Bhilary obstruction, hepatitis and cirrhosis

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Catharina

Office of In Vitro Diagnostic Device
Evaluation and Safety
(k) K053090

File: TBE RSP1_final.doc

Page 17 of 17

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.