SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM

K061879 · Hemodiagnostica, LLC · CFR · Dec 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061879
• Device Name: SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
• Applicant: Hemodiagnostica, LLC
• Product Code: CFR · Clinical Chemistry
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 used 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 Story

The SDI CA480 is a discrete, random access, microprocessor-controlled clinical chemistry analyzer; performs photometric assays (Glucose, BUN) and potentiometric ISE assays (Na+, K+, Cl-). Input: serum samples via primary tubes or sample cups. Photometric assays use enzymatic reactions (hexokinase for glucose; urease/GLDH for BUN) measured at 340 nm. ISE module uses ion-selective membrane electrodes to measure potential relative to a reference electrode. System throughput: 300 photometric tests/hr and 180 ISE tests/hr. Operated by clinical laboratory personnel in a professional setting. Output: quantitative concentration values displayed to the user. Healthcare providers use results for diagnosis and treatment of metabolic, renal, and electrolyte disorders. System includes automated cuvette washing, sample/reagent pipetting via stepper motors, and optical fluid detection.

Clinical Evidence

Bench testing only. Precision studies (within-run and total) performed per CLSI EP-05. Linearity validated across claimed ranges. Method comparison studies against predicate devices (n=60-67) showed high correlation (r=0.9761 to 0.9998). Analytical sensitivity, LoD, and LoQ established for all analytes. Interference testing performed for hemoglobin, bilirubin, and lipemia.

Technological Characteristics

Discrete, random access, microprocessor-controlled photometric analyzer. Features halogen lamp, filter wheel, photodiode detector, and reusable quartz cuvettes. Integrated ISE module for electrolytes. Throughput 480 tests/hour. Automated cuvette wash/dry system. Hardware-controlled robotics for fluid handling.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of Glucose, BUN, Sodium, Potassium, and Chloride in serum for patients requiring diagnosis or treatment of carbohydrate metabolism disorders, renal/metabolic diseases, or electrolyte imbalances.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Model 550 Express (k872302)
• Ciba Corning Model 664/FAST 4 System (k871028)

Submission Summary (Full Text)

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K06/879

Image /page/0/Picture/1 description: The image contains the logo for HemoDiagnostica. The logo features a cluster of small, irregular shapes on the left side. To the right of the shapes, the text "HemoDiagnostica" is written in a simple, sans-serif font.

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 [e-mail]

#### 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<br>§ 862.1600, § 862.1170, § 862.1665,<br>§ 862.1770, § 862.1345 |

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Image /page/1/Picture/0 description: The image contains the logo for HemoDiagnostica IVD Systems. The logo features a cluster of black dots arranged in a semi-circular shape on the left side. To the right of the dots, the text "HemoDiagnostica" is written in a simple, sans-serif font, with "IVD Systems" written in a smaller font size below it.

#### Indications for Use:

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.

#### 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) | Device<br>Class | Product<br>Code | Regulation |
|-------------------------------------------|-----------------------------------------|---------|-----------------|-----------------|------------|
| SDI CA480<br>Clinical Chemistry<br>System | Ciba Corning Model<br>550 Express | K872302 | I | JJE | 862.2160 |
| | Ciba Corning Model<br>664/Fast 4 System | K871028 | II | CEM | 862.1600 |
| | Ciba Corning Model<br>664/Fast 4 System | K871028 | II | CGZ | 862.1170 |
| | Ciba Corning Model<br>664/Fast 4 System | K871028 | II | JGS | 862.1665 |
| | UREA NITROGEN<br>(BUN) | K880078 | II | CDQ | 862.1770 |
| | GLUCOSE<br>HEXOKINASE | K880236 | II | CFR | 862.1345 |

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## 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.

#### 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 | Correlation<br>Coefficient |
|-------------------------|----------------|-------|-----------|----------------------------|
| 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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