(22 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard analytical measurements.
No
The device measures properties in blood, serum, plasma, and aqueous solutions. It is a diagnostic device for in-vitro analysis. It is not applied to the body to treat a medical condition.
Yes
The intended use explicitly states "The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate." These measurements are used to diagnose medical conditions.
No
The device description explicitly states it is an "analyzer," which is a hardware device used for measuring various parameters in blood samples. It is not described as software running on a general-purpose computing platform.
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 device is used for the measurement of various analytes (pH, PO2, PCO2, etc.) in samples of whole blood, serum, plasma, and aqueous solutions. These are all biological samples taken in vitro (outside the living body).
- Device Description: The "Device Description" further clarifies that it's a "combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test system." These are all types of tests performed on biological samples in vitro to provide diagnostic information.
- Classification: The device is classified under various sections of 21 CFR 862 and 864, which are regulations specifically for clinical chemistry and hematology devices, respectively. These categories are primarily for IVD devices.
Therefore, based on the provided information, the Roche Diagnostics Omni C Analyzer is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
Product codes (comma separated list FDA assigned to the subject device)
CEM, JFP, JGS, CGZ, CHL, GKR, GKF, GLY
Device Description
The Omni C analyzer represents a combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test system classified as a Class II device under various sections of 21 CFR 862 and 864 based on the individual test parameters measured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
NOV 0 2 2001
III. 510(k) Summary
1
K0133373
NOV 0 2 2001
510(k) Summary
..............................................................................................................................................................................
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| Contact Person: Jennifer Tribbett | |
| Date Prepared: October 9, 2001 | |
| 2) Device name | Proprietary name: Omni C Analyzer |
| Common name or Classification Name: pH, Blood Gas, Electrolyte, Hematocrit, Hemoglobin and Oxygen Saturation System | |
| 3) Predicate device | We claim substantial equivalence to the current legally marketed Omni Modular Analyzer (K990092). |
| 4) Device Description | The Omni C analyzer represents a combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test system classified as a Class II device under various sections of 21 CFR 862 and 864 based on the individual test parameters measured. |
| 5) Intended use | The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate. |
| Continued on next page |
:
2
510(k) Summary, Continued
Comparison to Predicate Device
| Similarities | The following is a list of some of the claims and features unaffected by the proposed modification. |
|---|---|
| -------------- | ----------------------------------------------------------------------------------------------------- |
| Feature/Claim | Detail |
|---|---|
| Intended use | In-vitro diagnostic device intended to measure blood gases, electrolytes, total |
| hemoglobin and hematocrit. | |
| Fundamental | |
| Technology | For electrolytes, PO2, PCO2, pH and hematocrit the technology is the same as |
| the Omni Modular, thickfilm enzymatic and electrochemical. For the tHb/SO2 | |
| module, the technology is the same as the Opti R, optical reflectance. | |
| Sample Type | Utilizes the same sample type (whole blood, serum, plasma, aqueous buffers, |
| QC materials) for each parameters as previously cleared on the Omni Modular | |
| for the electrolytes, hematocrit, PO2, PCO2 and pH and as the Opti R for | |
| tHb/SO2. | |
| Calibration | The liquid calibration system has the same calibration principle and utilizes the |
| same calibration reagent formulations as the Omni Modular. | |
| Device components | Omni C utilizes the same valves and peristaltic pump as those contained within |
| the Omni Modular. | |
| User Interface | Omni C uses the same GUI (touch screen) as the Omni Modular, except the |
| Omni C footprint is slightly smaller. |
Differences The following is a list of the claims and features affected by the proposed modification.
| Feature/Claim | Detail |
|---|---|
| Parameter | Incorporates a tHb/SO2 module which is not offered on the Omni Modular but |
| is a modification of the currently available Opti R tHb/SO2 module. | |
| Quality Control | Utilizes a different QC material due to the tHb/SO2 module. However, this |
| Quality Control formulation is based on the previously cleared OPTI-Check | |
| material. | |
| Software | Incorporates software that functions with the tHb/SO2 module. |
| Hardware features | Utilizes a new outer housing and a modified user interface to enhance the |
| intuitive features of the system. |
3
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 eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
NOV 0 2 2001
K013373 Re: Trade/Device Name: Omi C Analyzer Regulation Number: 21 CFR 862.1600; 21 CFR 862.1145; 21 CFR 862.1665; 21 CFR 862.1170; 21 CFR 862.1120; 21 CFR 864.5620;
21 CFR 864.5600; 21 CFR 864.7500 Regulation Name: Potassium test system; Calcium test system; Sodium test system; Chloride test system; Blood gases (P. 2, P.2) and blood pH test system; Automated hemoglobin system; Automated hematocrit instrument; Whole bood hemoglobin assays Regulatory Class: Class II; Class II; Class II; Class II; Class II; Class II; Class II; Class II Product Code: CEM; JFP; JGS; CGZ; CHL; GKR; GKF; GLY Dated: October 10, 2001 Received: October 11, 2001
Dear Ms. Tribbett:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the black in the 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 I ou may a controls provisions of the Act include requirements for annual registration, listing 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2
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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
NOV 0 2 2001
510(k) Number (if known): K0/3373 Device Name: Omni C Analyzer
Indications for Use:
The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
510/k) Numbe
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
CONFIDENTIAL
015