(109 days)
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, urca/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
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, bilirubin. hemoglobin, oxygen saturation, oxyhemoglobin, total deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
The provided text describes a 510(k) submission for a bilirubin assay rather than a medical device or AI algorithm with performance metrics like sensitivity, specificity, or AUC. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, not on demonstrating performance against clinical acceptance criteria in the way an AI diagnostic would.
Therefore, many of the requested categories for AI device studies (e.g., sample size of test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The document primarily discusses method comparison studies with existing commercial assays.
Here's an attempt to answer the questions based only on the provided text, highlighting the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the bilirubin assay in terms of diagnostic performance (e.g., sensitivity, specificity, or accuracy targets). Instead, it discusses "acceptable performance" through method comparison studies with predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to legally marketed predicate devices | "acceptable performance versus other analyzers" in method comparison studies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "The bilirubin parameter for use on the OMNI S Analyzer was compared to several legally marketed analyzers in the method comparison studies." However, it does not specify the sample size for these method comparison studies or the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For laboratory assays like this, "ground truth" is typically established by reference methods or validated predicate devices, not by expert interpretation in the same way as imaging diagnostics. The text does not mention any human experts establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in imaging or clinical studies where subjective human interpretation needs to be reconciled. For a bilirubin assay, results are quantitative measurements, and reconciliation would involve comparing numerical values, not subjective interpretations. The text does not mention any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a laboratory assay for measuring a biomarker, not an AI-assisted diagnostic device that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone device, which is what the OMNI S Analyzer with the bilirubin assay is. It operates without human interpretation of results in the diagnostic pipeline beyond reading the numerical output. The entire development process would inherently evaluate its standalone performance by comparing its results to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this bilirubin assay is established by comparison to results obtained from legally marketed predicate bilirubin assays on other analyzers (Roche Hitachi Analyzers, Radiometer ABL735, Beckman LX®20 System, Kodak Vitros System). These predicate devices are considered the "truth" for establishing equivalence.
8. The sample size for the training set
Not applicable. This is a chemical assay, not an AI algorithm. There is no concept of a "training set" in the context of developing this type of device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. 1) Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 Contact Person: Jennifer Tribbett Date Prepared: January 23, 2004 2) Device name Proprietary name: Bilirubin Assay on the OMNI S Analyzer Common name: Bilirubin (total and unbound) in the neonate test system Classification name: Bilirubin (total and unbound) in the neonate test system ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------3) Predicate The bilirubin parameter for use on the OMNI S Analyzer is substantially device equivalent to the legally marketed bilirubin assay on the Roche Hitachi Analyzers (K981632), the Radiometer ABL735 (K991417), the Beckman LX®20 System (K011213) and the Kodak Vitros System (K840880). The Roche Diagnostics OMNI S Analyzer is a fully automated critical care 4) Device Description analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin. hemoglobin, oxygen saturation, oxyhemoglobin, total deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate. 5) Intended use The OMNI S bilirubin claim is for the determination of neonatal bilirubin in newborns using whole blood samples.
MAY 1 4 2004
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The bilirubin parameter for use on the OMNI S Analyzer was compared to 6) Substantial equivalence several legally marketed analyzers in the method comparison studies. It was Similarities and compared to the bilirubin assay on the Roche Hitachi Analyzers (K981632), Differences the Radiometer ABL735 (K991417), the Beckman LX®20 System (K011213) and the Kodak Vitros System (K840880).
The OMNI S bilirubin claim is for the determination of neonatal bilirubin in newborns using whole blood samples. The primary predicate device is the Radiometer ABL735, which determines neonate bilirubin using the same sample type (whole blood).
The method comparison studies also showed acceptable performance versus other analyzers, the Roche Hitachi Analyzers (K981632), the Beckman LX®20 System (K011213), and the Kodak Vitros System (K840880), which claim the determination of bilirubin in serum and plasma.
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Image /page/2/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 stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2004
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46256
K040174 Trade/Device Name: Bilirubin Assay on the OMNI S Analyzer Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: Class I Product Code: MQM Dated: April 5, 2004 Received: April 7, 2004
Dear Ms. Tribbett:
Re:
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, 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 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 (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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS. D.V.M. 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 (if known): K040174
Device Name: Bilirubin Assay on the 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, urca/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
Office of In Vitro Diagno evice Evaluation and
510(k) K040174
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§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.