(81 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard analytical measurements.
No
The device is a critical care analyzer for measuring various parameters in blood samples, which is diagnostic rather than therapeutic.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate." Measuring these parameters in patient samples is a diagnostic activity.
No
The device description explicitly states it is a "fully automated critical care analyzer" and a "combined pH, blood gas, electrolyte, glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives, hematocrit and oxygen saturation test system." This indicates a physical hardware device that performs measurements on biological samples, not a software-only device.
Yes, the Roche Diagnostics Omni S Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions". This involves testing samples taken from the body (in vitro) to provide diagnostic information.
- Device Description: It's described as a "combined pH, blood gas, electrolyte, glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives, hematocrit and oxygen saturation test system". This further confirms its function as a diagnostic testing device.
- Classification: It's classified as a Class II device based on the individual test parameters measured, which is a common classification for IVD devices.
The core function of the device is to analyze biological samples outside of the body to provide information about a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
Product codes
CEM, JFP, JGS, CGZ, CHL, KHP, CGA, CDS, GKR, GGZ, GKF, GHS, KHG
Device Description
The Omni S analyzer represents a combined pH, blood gas, electrolyte, glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives, hematocrit and oxygen saturation test system classified as a Class II device based on the individual test parameters measured.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K032-311
OCT 17 2003
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: July 25, 2003 |
| 2) Device name | Proprietary name: Omni S Analyzer
Common name or Classification Name: Automated analyzer for the
measurement of pH, blood gases, electrolytes, hematocrit, glucose, lactate,
urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin,
deoxyhemoglobin, carboxyhemoglobin and methemoglobin. |
| 3) Predicate
device | We claim substantial equivalence to the current legally marketed Omni
Modular Analyzer (K990092) and the Omni C Analyzer (K013373). |
| 4) Device
Description | The Omni S analyzer represents a combined pH, blood gas, electrolyte,
glucose, lactate, urea/BUN, total hemoglobin, hemoglobin derivatives,
hematocrit and oxygen saturation test system classified as a Class II device
based on the individual test parameters measured. |
| 5) Intended use | The Roche Diagnostics Omni S Analyzer is a fully automated critical care
analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium,
potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN,
total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin,
carboxyhemoglobin and methemoglobin in samples of whole blood, serum,
plasma and aqueous solutions as appropriate. |
Continued on next page
1
Comparison to Predicate Device
- Intended Use As shown in the following comparison table the intended use of the OMNI S covers the measurements of the parameters currently available on the OMNI Modular system with the addition of the oxygen saturation parameter of the OMNI C.
| Topic | OMNI S Analyzer | OMNI Modular Analyzer
(K990092) | OMNI C Analyzer
(K013373) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Omni S Analyzer is intended to
be used for the measurement of
pH, PO2, PCO2, sodium,
potassium, ionized calcium,
chloride, hematocrit, glucose,
lactate, urea/BUN, total
hemoglobin, oxygen saturation,
oxyhemoglobin,
deoxyhemoglobin,
carboxyhemoglobin and
methemoglobin in samples of
whole blood, serum, plasma and
aqueous solutions as appropriate. | Omni Modular Analyzer is
intended to be used for the
measurement of pH, PCO2, PO2,
total hemoglobin,
deoxyhemoglobin,
oxyhemoglobin,
carboxyhemoglobin,
methemoglobin, sulfhemoglobin,
sodium, potassium, chloride,
ionized calcium, hematocrit,
glucose, lactate and urea
nitrogen, in samples of whole
blood, serum, plasma and
aqueous solutions as appropriate. | 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. |
2
Comparison to Predicate Device, Continued
| Similarities and
differences from
predicate devices | The information listed below describes the similarities and differences
between the Omni S analyzer and the predicate Omni Modular and Omni C
analyzers. |
| ----------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Topic | Description |
|---|---|
| Parameters Measured | pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, |
| lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, | |
| deoxyhemoglobin, carboxyhemoglobin and methemoglobin | |
| Same as the combination of Omni Modular and Omni C parameters. | |
| Omni Modular: pH, PCO2, PO2, total hemoglobin, deoxyhemoglobin, | |
| oxyhemoglobin, carboxyhemoglobin, methemoglobin, sulfhemoglobin sodium, | |
| potassium, chloride, ionized calcium, hematocrit, glucose, lactate and urea nitrogen | |
| Omni C: pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, | |
| total hemoglobin, and oxygen saturation | |
| Sample Types | Same as Omni Modular and Omni C: |
| Whole blood, serum, plasma and aqueous (QC material and dialysis) solutions | |
| Blood Gases (pO2, | |
| pCO2, pH) | The Omni S has incorporated the same blood gas modules as utilized in the Omni |
| Modular and Omni C analyzers. | |
| ISE (sodium, | |
| potassium, calcium, | |
| chloride) | The Omni S has incorporated the same ISE modules as utilized in the Omni Modular |
| and Omni C analyzers. | |
| tHB and SO2 | The Omni S has incorporated the same tHb (total hemoglobin ) and SO2 (oxygen |
| saturation) sensor as utilized in the Omni C analyzer. | |
| MSS (glucose, | |
| lactate, urea/BUN) | |
| chamber | The Omni S has incorporated similar types of MSS sensors as utilized in the Omni |
| Modular analyzer; however, the Omni S uses Braunstein instead of PACE technology | |
| for the glucose and lactate parameters. | |
| The Omni S MSS chamber also incorporates some enhancements. The sample | |
| detection feature has been improved and the MSS chamber contains an additional | |
| junction in the front to allow for direct aspiration of standby solution. | |
| Reagent Supply | The Omni S will provide enhanced customer convenience by utilizing two reagent |
| packs (7 incorporated pouches) plus two bottles instead of the fourteen bottles | |
| currently used on the Omni Modular system. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 17 2003
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K032311 Trade/Device Name: Omni S. Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system Regulatory Class: Class II Product Code: CEM: JFP; JGS; CGZ; CHL;KHP; CGA; CDS;GKR; GGZ; GKF; GHS; KHG Dated: July 25, 2003 Received: July 28, 2003
Dear Ms. Tribbett:
Re:
We have reviewed vour 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 vour 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).
4
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): Device Name: Omni S Analyzer
Indications for Use:
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin 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)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K032311
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)