(68 days)
Not Found
No
The summary describes a calibrator solution for in vitro diagnostic assays, with no mention of AI or ML technology in its function or description.
No.
The device is an in vitro diagnostic calibrator, used to calibrate assays for diagnostic purposes, not to treat a disease or condition.
Yes
This device is a calibrator for in vitro diagnostic use, which means it helps ensure the accuracy of diagnostic assays. While not a diagnostic device itself, it is explicitly intended for use with diagnostic devices (ADVIA IMS Chemistry systems) and processes (assays) to enable their diagnostic function. Furthermore, its intended use statement specifies "for in vitro diagnostic use."
No
The device description explicitly states it is a "human serum based solution containing various nonhuman constituents," indicating it is a physical calibrator material, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Bayer ToxAmmonia Calibrator is intended for in vitro diagnostic use..." This is the most direct indicator.
- Device Description: The description mentions it's a "human serum based solution containing various nonhuman constituents at defined concentrations." This type of material, used to calibrate assays that measure substances in biological samples (like serum), is characteristic of IVD products.
- Performance Studies: The description of performance studies focuses on the stability and performance of the calibrator in relation to its intended use in assays, which is relevant to the quality and reliability of an IVD.
- Predicate Device: The mention of a "Predicate Device" with a K number (K030169) and name ("SetPoint Chemistry Calibrator") strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
Therefore, the information clearly indicates that the Bayer ToxAmmonia Calibrator is intended and designed for use in in vitro diagnostic procedures.
N/A
Intended Use / 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.
Product codes
75 JIX
Device Description
The Toxammonia Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 ToxAmmonia
Calibrator | Bayer SETpoint™
Calibrator for
Automated Systems |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | For use as a calibrator of
clinical chemistry assays
for automated analytical
procedures. |
| Format | Liquid human serum
albumin base to which
appropriate nonhuman
constituents have been
added to achieve specific
concentrations. | Lyophilized bovine serum
base to which
appropriate nonhuman
constituents have been
added to achieve specific
concentrations. |
| Stability | Stable at 2-8°C until
the expiration date
printed on label. Stable 3 days after
opening when
refrigerated at 2-8°C. | Stable at 2-8°C until
last day of the month
(expiration date)
printed on the label. Stable 48 hours when
reconstituted
according to
directions when
refrigerated at 2-8°C
and protected from
light with the
exception of total and
direct bilirubin, which |
7. Comparison to Predicate Device
2
| | | are stable for eight
hours. |
|--------|--------------|--------------------------------|
| 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 |
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 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
5
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)