The SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. BUN measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and are used in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

Device Description

The SDI CA480 is a discrete, random access, microprocessor controlled photometric analyzer with the capability to perform 300 clinical chemistry tests per hour with an additional 180 ISE tests per hour for a total throughput of 480 tests per hour.

The analyzer is comprised of three main components: sample system, reagent system, and measurement system. The analyzer utilizes hardware controlled robotics for pipetting, transport, dispensing and stirring of reagents and samples, The measurement system features a halogen lamp, filter wheel and photodiode for optical detection and reusable quartz reaction cuvettes which are automatically washed and dried between samples. The integrated ISE module allows for Na/K/Cl electrolyte tests.

AI/ML Overview

The provided document describes the SDI CA480 Clinical Chemistry System, a device designed for in-vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium, and Chloride in serum. The study presented aims to demonstrate the substantial equivalence of the SDI CA480 to its predicate devices, the Ciba Corning Model 550 Express Clinical Chemistry Analyzer and the Model 664/FAST 4 System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the "Summary of Substantial Equivalence" which states that the SDI CA480 is "substantially equivalent" to the predicate devices in design, intended use, and technology. The performance aspects of this substantial equivalence are quantitative, focusing on the agreement between measurements made by the new device and the predicate devices. This agreement is expressed through slope, intercept, and correlation coefficient derived from method comparison studies.

Assay	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Slope)	Reported Device Performance (Intercept)	Reported Device Performance (Correlation Coefficient)
ISE Sodium Electrode	Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation)	0.998	-1.26	0.9905
ISE Potassium Electrode	Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation)	0.977	0.06	0.9946
ISE Chloride Electrode	Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation)	1.02	-2.34	0.9761
Urea Nitrogen (BUN)	Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation)	0.933	0.94	0.9988
Glucose HK	Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation)	0.980	1.34	0.9998

The reported performance values for slope are all close to 1, intercepts are close to 0, and correlation coefficients are all very close to 1, indicating strong agreement with the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 60 real patient samples were used for the method comparison study.
Data Provenance: The samples are described as "real patient samples," suggesting a clinical setting. The country of origin is not specified, nor is whether the data was retrospective or prospective. Given the medical device submission context, it is highly likely these were prospectively collected clinical samples for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of diagnostic device (clinical chemistry analyzer) does not typically rely on human expert interpretation of results for ground truth in the same way imaging devices do. Instead, the "ground truth" for method comparison is usually established by using an existing, legally marketed, and accepted predicate device. No human experts are directly used to establish a subjective "ground truth" for each sample's measurement values. The predicate devices themselves serve as the reference.

4. Adjudication method for the test set

Not applicable. As described above, this study compares the performance of a new instrument against established predicate instruments. There is no 'adjudication' process involving human experts to resolve discrepancies in measurement values, as the predicate device's measurement is taken as the reference for comparison.

5. 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 device is a fully automated clinical chemistry analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was conducted. The "Method Comparison Data" section details the performance of the SDI CA480 itself by comparing its measurements to those of the predicate devices. This is an evaluation of the algorithm/instrument's performance without human intervention in the measurement process (beyond initial sample loading and instrument operation).

7. The type of ground truth used

The ground truth for this method comparison study is the measurements obtained from the legally marketed predicate devices (Ciba Corning Model 550 Express and Model 664/Fast 4 System). These predicate devices are presumed to provide accurate and reliable measurements based on their prior 510(k) clearances.

8. The sample size for the training set

Not applicable explicitly. For this type of clinical chemistry system, there isn't a "training set" in the machine learning sense. The device's internal algorithms and calibration are established during its development and manufacturing. The data used in this submission is for validation and demonstration of substantial equivalence, not for training a model.

9. How the ground truth for the training set was established

Not applicable. As mentioned above, a "training set" with established ground truth as in machine learning is not described or typically relevant for the 510(k) clearance of an automated clinical chemistry analyzer based on chemical reactions and photometric detection. Device calibration and internal parameters are set through manufacturing and quality control processes based on known standards and reference materials.

Summary

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K06/879

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Pre-market Notification 510(k) Submission SDI CA480 Clinical Chemistry System

510k Summary

DEC 1 0 2006

Purpose of Application:

New 510(k) for instrument – instrument performance was established with previously 510(k) cleared assays.

Establish CLIA registration for submitted assays.

Submitter Information:

HemoDiagnostica 19) Systems

Contact Name: Company Name and Address:

Registration Number: Tel: Fax: email:

Bruno Borganti HemoDiagnostica, LLC 345 Freshfields Drive Johns Island SC, 29455 3004432492 843 277 1642 843 277 0903 bb@hemodiagnostica.com

Date of Submission:

June 29th, 2006

Name of Product:

SDI CA480 Clinical Chemistry System Saturno 300 Clinical Chemistry System

SDI CA480 Clinical Chemistry System Device Classification:

Device Classification:	II
Product Codes:	JJE and subsequent CEM, CGZ, JGS, CDQ, CFR
Regulation Sections	21 CFR § 862.2160 and subsequent§ 862.1600, § 862.1170, § 862.1665,§ 862.1770, § 862.1345

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Indications for Use:

Predicate Device:

Ciba Corning Model 550 Express Clinical Chemistry Analyzer 510(k): K872302

Ciba Corning Model 664/Fast 4 System 510(k): K871028

The following table describes the predicate devices, classifications, corresponding regulations, and product codes associated with this submission.

New Product	Predicate Device	510(K)	DeviceClass	ProductCode	Regulation
SDI CA480Clinical ChemistrySystem	Ciba Corning Model550 Express	K872302	I	JJE	862.2160
	Ciba Corning Model664/Fast 4 System	K871028	II	CEM	862.1600
	Ciba Corning Model664/Fast 4 System	K871028	II	CGZ	862.1170
	Ciba Corning Model664/Fast 4 System	K871028	II	JGS	862.1665
	UREA NITROGEN(BUN)	K880078	II	CDQ	862.1770
	GLUCOSEHEXOKINASE	K880236	II	CFR	862.1345

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Device Description:

Summary of Substantial Equivalence:

The SDI CA480 Clinical Chemistry System is substantially equivalent to the Ciba Corning Model 550 Express Clinical Chemistry Analyzer and the Model 664/FAST 4 System in design, intended use, and technology.

Method Comparison Data:

To demonstrate substantial equivalence between the SDI CA480 and the predicate devices Model 550 Express and Model 664, previously 510(k) cleared assays were tested on each appropriate instrument. A comparison analysis was performed between the SDI CA480 and the Model 550 Express and Model 664 for 60 real patient samples. The results are summarized below.

Assay	Sample Type	Slope	Intercept	CorrelationCoefficient
ISE Sodium Electrode	Serum / Plasma	.998	-1.26	.9905
ISE Potassium Electrode	Serum / Plasma	.977	0.06	.9946
ISE Chloride Electrode	Serum / Plasma	1.02	-2.34	.9761
Urea Nitrogen (BUN)	Serum / Plasma	.933	0.94	.9988
Glucose HK	Serum / Plasma	.980	1.34	.9998

Conclusion:

The SDI CA480 Clinical Chemistry System and the Ciba Corning Model 550 Express system combined with optional Model 664/Fast 4 ISE system are substantially equivalent in design, intended use, and in performance.

Bruno Borganti

Confidential

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bruno Borganti HemoDiagnostica, LLC 130 Gardeners Circle Suite 302 Johns Island, SC 29455

DEC 1 5 2006

Re: K061879 Trade Name: SDI CA480 Clinical Chemistry System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR, CDN, JGS, CEM, CGZ, JJE Dated: November 22, 2006 Received: November 27, 2006

Dear Mr. Borganti:

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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions 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 Division 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 Gutierrez, Ph.D.

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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Indications for Use

510(k) Number:

K061879

Device Name:

SDI CA480 Clinical Chemistry System

Indications for Use:

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Confidential

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

Office of In Vitro Diagnostic Device
Tralcation and Safety

K061879

A1-01

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.