(165 days)
Not Found
No
The description focuses on standard clinical chemistry analyzer components and functions, with no mention of AI/ML terms or capabilities.
No
This device is an in vitro diagnostic (IVD) system used for quantitative measurements of various analytes in serum, which aids in the diagnosis and monitoring of diseases, rather than providing direct therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum," and that these measurements "are used in the diagnosis and treatment of" various diseases.
No
The device description explicitly details hardware components such as a photometric analyzer, sample system, reagent system, measurement system with a halogen lamp, filter wheel, photodiode, reusable quartz reaction cuvettes, and an integrated ISE module. This indicates it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum."
- Device Description: The description details a system designed to perform clinical chemistry tests on biological samples (serum).
- Performance Studies: The performance studies involve testing real patient samples to compare the device's performance to predicate devices for diagnostic assays.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / 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.
Product codes
JJE, CEM, CGZ, JGS, CDQ, CFR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
photometric
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
| Assay | Sample Type | Slope | Intercept | Correlation 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 |
Predicate Device(s)
K872302, K871028, K880078, K880236
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 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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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
Class | Product
Code | Regulation |
|-------------------------------------------|-----------------------------------------|---------|-----------------|-----------------|------------|
| SDI CA480
Clinical Chemistry
System | Ciba Corning Model
550 Express | K872302 | I | JJE | 862.2160 |
| | Ciba Corning Model
664/Fast 4 System | K871028 | II | CEM | 862.1600 |
| | Ciba Corning Model
664/Fast 4 System | K871028 | II | CGZ | 862.1170 |
| | Ciba Corning Model
664/Fast 4 System | K871028 | II | JGS | 862.1665 |
| | UREA NITROGEN
(BUN) | K880078 | II | CDQ | 862.1770 |
| | GLUCOSE
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
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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Page 2 -
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:
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
A1-01