(68 days)
Bayer ToxAmmonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.
The Toxammonia Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
The provided document describes a medical device submission for a ToxAmmonia Calibrator and its comparison to a predicate device. It is a calibrator for in-vitro diagnostic assays, not an AI/ML powered device. Due to the nature of the device (a calibrator solution) and the provided text, many of the requested fields are not applicable in the context of an AI/ML device study.
Here's an analysis based on the provided text, indicating "Not Applicable" for fields that do not fit this type of device or for which information is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on ADVIA IMS Chemistry systems. | Calibrator is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS chemistry systems. |
| Format | Liquid human serum-based solution with nonhuman constituents. | Liquid human serum albumin base to which appropriate nonhuman constituents have been added. |
| Stability at 2-8°C (Unopened) | Stable until expiration date. | Stable at 2-8°C until the expiration date printed on label. |
| Stability at 2-8°C (Opened) | Stable for 3 days. | Stable 3 days after opening when refrigerated at 2-8°C. |
| Levels | Single Level for all constituents. | Single Level. |
Study Proving Device Meets Acceptance Criteria:
The document states, "The stability of the Toxammonia calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material." This indicates a stability study was performed. The primary acceptance criterion appears to be comparable performance and functional equivalence to the predicate device, specifically regarding its use as a calibrator and its stability characteristics. The submission focuses on demonstrating that the new calibrator has similar characteristics to existing commercial products intended for similar use.
2. Sample size used for the test set and the data provenance:
- Sample Size: "three separate lots of calibrator material" were used for stability validation.
- Data Provenance: Not specified, but likely internal laboratory testing by Bayer Healthcare. This is not
retrospective or prospective data in the clinical sense, but rather a product validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a calibrator, "ground truth" refers to the known, precisely manufactured concentrations of analytes within the calibrator solution itself, established through analytical chemistry methods during production, not by expert interpretation.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods are typically employed in studies involving human interpretation or uncertain outcomes (e.g., medical image reading). For a chemical calibrator, performance is assessed through analytical measurements and stability testing against defined chemical standards.
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 not an AI/ML-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- Analytical Chemistry Standards / Known Concentrations: The "ground truth" for a calibrator refers to the precisely known concentrations of the target analytes (Acetaminophen, Ammonia, Ethanol, Salicylate) that are formulated into the calibrator solution during manufacturing. These concentrations are established through rigorous analytical chemistry methods.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML model. The calibrator itself undergoes manufacturing and quality control, not a training process.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant. The "ground truth" for the calibrator's stated concentrations is established through the manufacturing process and quality control release testing, ensuring the stated analyte levels are achieved.
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Assigned 510(k) number: K031683
Bayer Healthcare
ToxAmmonia Calibrator
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Contact person:
Kenneth T. Edds Ph.D.
Address: Bayer Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591
| Phone: | (914) 524-2446 |
|---|---|
| FAX: | (914) 524-2500 |
| e-mail: | ken.edds.b.@bayer.com |
Date Summary Prepared:
- Device Information
Proprietary Name: Common Name:
Toxammonia Calibrator Calibrator for multiple analytes
Classification Name: Class: CFR: Product Code:
Calibrator §862.1150. Class II 862.1150 75 JIX
August 6, 2003
Contract Manufacturing Site: Medical Analysis Systems, Inc. (MAS) 5300 Adolfo Rd. Camarillo, CA 93012
3. Predicate Device Information
Name: SetPoint Chemistry Calibrator
Contract Manufacturing Site: Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645
510(k) Number:
K030169
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4. Device Description
The Toxammonia Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
5. Statement of Intended Use
Bayer Toxammonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.
6. Product Performance
The stability of the Toxammonia calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use.
| Characteristic | Bayer ToxAmmoniaCalibrator | Bayer SETpoint™Calibrator forAutomated Systems |
|---|---|---|
| Intended Use | Bayer ToxAmmoniaCalibrator is intended forin vitro diagnostic use tocalibrate acetaminophen,ammonia, ethanol andsalicylate assays on theADVIA IMS chemistrysystems. | For use as a calibrator ofclinical chemistry assaysfor automated analyticalprocedures. |
| Format | Liquid human serumalbumin base to whichappropriate nonhumanconstituents have beenadded to achieve specificconcentrations. | Lyophilized bovine serumbase to whichappropriate nonhumanconstituents have beenadded to achieve specificconcentrations. |
| Stability | Stable at 2-8°C untilthe expiration dateprinted on label. Stable 3 days afteropening whenrefrigerated at 2-8°C. | Stable at 2-8°C untillast day of the month(expiration date)printed on the label. Stable 48 hours whenreconstitutedaccording todirections whenrefrigerated at 2-8°Cand protected fromlight with theexception of total anddirect bilirubin, which |
7. Comparison to Predicate Device
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| are stable for eighthours. | ||
|---|---|---|
| Levels | Single Level | Single Level |
Comparison of Constituent Analytes in predicate device and proposed Bayer ToxAmmonia Calibrator
| Bayer ToxAmmonia Calibrator(New Device) | Bayer SETpoint™ Chemistry Calibrator(Predicate Device) |
|---|---|
| ACETAMINOPHEN | ALBUMIN |
| AMMONIA | BILIRUBIN, DIRECT |
| ETHANOL | BILIRUBIN, TOTAL |
| SALICYLATE | CALCIUM |
| CHOLESTEROL | |
| CREATININE | |
| GLUCOSE | |
| IRON | |
| MAGNESIUM | |
| PHOSPHORUS, INORGANIC | |
| TOTAL PROTEIN | |
| TRIGLYCERIDES | |
| UREA NITROGEN | |
| URIC ACID | |
| SODIUM | |
| POTASSIUM | |
| CHLORIDE |
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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 eagle with three curved lines representing its wings. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds. Ph.D. Manager. Regulatory Affairs Bayer HealthCare 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K031683
Trade/Device Name: ToxAmmonia Calibrator Regulation Number: 21 CFR § 862.1150 Regulation Name: Multianalyte Calibrator Regulatory Class: II Product Code: JIX Dated: May 23, 2003 Received: June 12, 2003
Dear Dr. Edds:
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.
AUG - 6 2003
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). 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.
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Page 2 -
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 Sutman
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
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Page 1 of 1
510(k) Number: Қозы 683
Device Name: ToxAmmonia Calibrator
Indications for Use:
Bayer ToxAmmonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Carol C Benson for Jean Cooper, DVM |
| Division Sign-Off |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K031683 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-CounterUse |
(Optional Format 1-2-96)
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.