Who is the manufacturer of ROCHE DIAGNOSTICS OMNI S ANALYZER?

Roche Diagnostics Corp. filed the 510(k) submission for ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311).

What is the FDA product code for ROCHE DIAGNOSTICS OMNI S ANALYZER?

CEM. It is classified under 21 CFR 862.1600 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ROCHE DIAGNOSTICS OMNI S ANALYZER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ROCHE DIAGNOSTICS OMNI S ANALYZER?

Omni Modular Analyzer (K990092); Omni C Analyzer (K013373).

Who can help prepare an FDA 510(k) submission like ROCHE DIAGNOSTICS OMNI S ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ROCHE DIAGNOSTICS OMNI S ANALYZER

K032311 · Roche Diagnostics Corp. · CEM · Oct 17, 2003 · Clinical Chemistry

Device Facts

Record ID	K032311
Device Name	ROCHE DIAGNOSTICS OMNI S ANALYZER
Applicant	Roche Diagnostics Corp.
Product Code	CEM · Clinical Chemistry
Decision Date	Oct 17, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1600
Device Class	Class 2

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.

Device Story

Omni S Analyzer is a fully automated critical care analyzer; measures pH, blood gases, electrolytes, hematocrit, glucose, lactate, urea/BUN, and hemoglobin derivatives. Inputs: whole blood, serum, plasma, or aqueous solutions. Operation: utilizes blood gas, ISE, and MSS sensor modules; incorporates Braunstein technology for glucose/lactate; features enhanced sample detection and standby solution aspiration. Output: quantitative analytical results for the measured parameters. Used in clinical settings by healthcare professionals to support critical care decision-making. Benefits: provides rapid, comprehensive diagnostic data from a single platform, improving workflow efficiency via consolidated reagent packs.

Clinical Evidence

Bench testing only. The device demonstrates substantial equivalence through comparative analysis of sensor modules, sample types, and analytical performance parameters against the predicate Omni Modular and Omni C systems.

Technological Characteristics

Automated critical care analyzer. Sensing principles: blood gas modules, Ion Selective Electrodes (ISE), and MSS sensors (Braunstein technology). Parameters: pH, PO2, PCO2, electrolytes, hematocrit, glucose, lactate, urea/BUN, and hemoglobin derivatives. Reagent system: two reagent packs (7 pouches) and two bottles. Connectivity: standalone analyzer. Software: automated analysis and sample detection.

Indications for Use

Indicated for the measurement of pH, blood gases, electrolytes, hematocrit, glucose, lactate, urea/BUN, and hemoglobin derivatives in whole blood, serum, plasma, and aqueous solutions. Intended for use in critical care settings.

Regulatory Classification

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.

Predicate Devices

Omni Modular Analyzer (K990092)
Omni C Analyzer (K013373)

Related Devices

K972733 — AVL OMNI ANALYZER · Avl Scientific Corp. · Sep 9, 1997
K092686 — ABL90 FLEX SERIES · Radiometer Medical Aps · Aug 6, 2010
K110648 — NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM · Nova Biomedical Corporation · Aug 29, 2011
K990092 — AVL OMNI MODULAR ANALYZER · Avl Scientific Corp. · Jan 29, 1999
K160153 — ABL90 FLEX PLUS · Radiometer Medical Aps · Nov 4, 2016

Submission Summary (Full Text)

{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)