SIGMA DIAGNOSTICS CREATININE REAGENT KIT by SIGMA DIAGNOSTICS, INC.

This document describes a diagnostic reagent set, not a device that involves artificial intelligence, image analysis, or complex algorithms that would require the specified criteria like expert ground truth, MRMC studies, or multi-reader scenarios. The "device" in this context is primarily a chemical reagent.

Therefore, many of the requested categories are not applicable to the information provided. However, I can extract the relevant performance data and address the applicable points.

Here's the information based on the provided text for the Sigma Diagnostics CX®3 Creatinine Reagent Set:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Correlation with Predicate Device (Serum)	High correlation (implied: close to 1)	0.999
Regression (Serum)	Regression equation close to y=x (implied: slope near 1, intercept near 0)	y = 1.03x - 0.01
Correlation with Predicate Device (Urine)	High correlation (implied: close to 1)	0.998
Regression (Urine)	Regression equation close to y=x (implied: slope near 1, intercept near 0)	y = 0.99x + 0.21
Within-run Precision (%CV) - Serum	%CV < 4.5% (explicitly stated)	< 4.5 %
Total Precision (%CV) - Serum	%CV < 4.5% (explicitly stated)	< 4.5 %
Within-run Precision (%CV) - Urine	%CV < 2.1% (explicitly stated)	< 2.1 %
Total Precision (%CV) - Urine	%CV < 2.1% (explicitly stated)	< 2.1 %
Linearity - Serum	Linear to 25 mg/dL (explicitly stated)	To 25 mg/dL
Linearity - Urine	Linear from 10 to 400 mg/dL (explicitly stated)	From 10 to 400 mg/dL

Note: The acceptance criteria are largely implied based on typical performance expectations for medical devices of this type when demonstrating substantial equivalence, with specific precision and linearity values explicitly stated as met.

Additional Study Information:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "serum samples" and "urine samples" in the context of comparison studies and precision, but does not provide the specific number of samples for each.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective comparison studies conducted as part of the reagent's validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a chemical assay, not a device requiring expert interpretation of images or complex data. The "ground truth" would be established by the reference method (Beckman Creatinine Reagent Kit) for comparison studies.
Adjudication method for the test set: Not applicable. This concept applies to cases where human interpretation is involved.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a chemical assay, not an AI-powered diagnostic device involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The performance described is standalone algorithm (reagent) performance. There is no human-in-the-loop component for the direct measurement process of the reagent. The device (SYNCHRON CX 3 System) provides the automated measurement.
The type of ground truth used: For the comparison studies, the "ground truth" was established by the predicate device, the Beckman Creatinine Reagent Kit (Part No. 443340), run on the SYNCHRON CX 3 System. In essence, the performance of the new reagent was compared against an already established and cleared method.
The sample size for the training set: Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable. There is no training set for this type of medical product.

Summary

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K963534

SEP 30 1998

510(K) NOTIFICATION

Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103

CX®3 Creatinine Reagent Set Procedure Number C7058 August 31, 1996

SUMMARY OF SAFETY AND EFFECTIVENESS

Creatinine is synthesized in the kidney, the liver, and the pancreas.1 It is transported in the blood to other organs such as muscle and brain where it is phosphorylated to phosphocreatine. Some free creatine in muscle is converted to creatinine daily, and the amount of creatinine produced is proportional to muscle mass. In the absence of renal disease, the excretion rate of creatinine in an individual is relatively constant. Therefore, measurement of creatinine clearance is useful in detecting renal disease and estimating the extent of impairment of renal function.2

Most methods for creatinine measurement are based on the Jaffe reaction, where yellow/orange color forms when the metabolite is treated with alkaline picrate.3 The Sigma Diagnostics Creatinine Reagent Set for the SYNCHRON CX 3 is formulated based on a modification of the Jaffe reagents described by Heinegard and Tiderstrom. These modifications minimize the effect of interfering substances.4

The safety and effectiveness of Sigma Diagnostics Creatinine Reagent Set, Procedure Number C7058, is demonstrated by its substantial equivalency to Beckman Creatinine Reagent Kit, Part No. 443340. Both creatinine reagents are used to measure creatinines concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System, and the reaction principles for both reagents are identical. In comparison studies, a correlation coefficient of 0.999 and a regression equation of v = 1.03x - 0.01 was obtained with serum samples: and a correlation coefficient of 0.998 and a regression equation of y = 0.99x + 0.21 was obtained with urine samples. With-in run precision and total precision demonstrated %CV's of less than 4.5 % on serum samples and less than 2.1 % on urine samples. The Sigma Diagnostics Creatinine Reagent has been determined to be linear to 25 mg/dL with serum samples, and from 10 to 400 mg/dL with urine samples on the SYNCHRON CX 3 System.

REFERENCES:

1. Tietz NW: Textbook of clinical chemistry. WB Saunders, Philadelphia, 1986, pp 1271 -1281.
1. Bowers LD. Wong ET: Kinetic serum creatinine assays. Ill. An initial evaluation and review. Clin Chem 26:555, 1980
1. Jaffe M: Ueber den Niederschlag, welchen Picrinsaure in narmalen Harm eraeugt und uber eine neue Reaction des Kreatinins. Hoppe Seylers Z Physiol Chem 10:391, 1886
1. Tietz, NW, Clinical Guide to Laboratory Tests, WB Saunders, Co, Philadelphia, 1983

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.