(49 days)
This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.
The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.
This document describes the Thermo Trace Ammonia Standards Set, which is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent to establish points of reference for the determination of Ammonia in human plasma.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes the process for establishing and validating the values of the Thermo Trace Ammonia Standards Set rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. Instead, the "acceptance criteria" are implied by the methods used to ensure the quality and accuracy of the standards.
| Acceptance Criteria (Implied) | Reported Device Performance/Method of Verification |
|---|---|
| Purity/Composition | Specified amount of Anhydrous Ammonium Sulfate accurately weighed on a calibrated analytical balance and dissolved in Class A volumetric flask with ammonia-free deionized water (<1 micromole/Liter). |
| Value Assignment | Values assigned by gravimetric composition. Confirmed in accordance with Thermo Trace Ammonia Standard Production Specification document number PS345/00. |
| Lot-to-Lot Consistency | Each lot of standard is tested with Thermo Trace Ammonia DST reagent, using a previously approved standard lot as a control. |
| Accuracy/Traceability | Commercially available controls (Roche Preciset NH3) are included in the verification assay to serve as additional controls on the accuracy of the standard material on an ongoing basis. |
| Stability/Shelf Life | Product stability determined by performing accelerated stability studies (stressed at three temperatures for a pre-defined period). Real-time testing is conducted to further validate the established dating. Real-time data collection is ongoing. |
| Instrument Compatibility | Analytical use of the Cobas Mira in testing this product(s) is described in procedure number PS345/00. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm evaluation. Instead, the performance and value assignment are based on quality control and validation procedures for each lot of the standard.
- Test Set Sample Size: Not applicable in the context of an AI device. The document mentions "each lot of standard" being tested.
- Data Provenance: The studies are internal to Thermo DMA and involve laboratory testing of manufactured standards. The data is prospective for ongoing quality control and stability monitoring. The country of origin is implicitly the USA (Thermo DMA, Arlington, TX).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of an AI device. The "ground truth" for these chemical standards is established through gravimetric composition and analytical testing, overseen by qualified laboratory personnel and conforming to internal specifications.
4. Adjudication Method for the Test Set
Not applicable as this is not an AI device or a diagnostic study requiring expert adjudication of results. The "adjudication" is based on adherence to predefined chemical and analytical specifications (e.g., PS345/00, PS3435/00).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a chemical standard set, not an AI diagnostic tool that requires human interpretation or assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not an algorithm-based device. The "performance" is intrinsic to the accuracy and stability of the chemical composition of the standards. The validation involves analytical testing of these standards.
7. The Type of Ground Truth Used
The ground truth for the value assignment and composition of the standards is based on:
- Gravimetric Composition: Accurately weighing the specified amount of Anhydrous Ammonium Sulfate.
- Reference Materials: Testing against previously approved standard lots and commercially available controls (Roche Preciset NH3).
- Analytical Specifications: Adherence to defined production specification documents (e.g., PS345/00).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a training set. The "training" in a broad sense involves the processes and procedures established for manufacturing and quality control.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI device. The "ground truth" for the production and quality control processes is based on established chemical principles, gravimetric measurements, and analytical validation against reference materials and internal specifications.
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Thermo DMA
845 Avenue G East Arlington, TX 76011-7709
510 (k) Summary
(817)607-1700 Fax: (817) 649-2461 www.thermodma.com
This Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter: Thermo DMA, Inc.
Address: 845 Avenue G East Arlington, Texas 76011
Contact Person: Thomas Dollar, Manager of Regulatory Affairs
The assigned 510(k) number is
Product Code: JIS, Calibrator, primary
Device Name: Thermo Trace Ammonia Standards Set
Device Class: II
Description and Intended Use: The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.
Storage and Stability: Product stability was determined by performing accelerated stability studies as per Thermo Trace's product stability acocierating Procedure (SOP). The standards were stressed at three temperatures (minimum) for a pre-defined period of time, and then tested to ensure that stressed standards continue to meet performance specifications. Based on the results of these studies, a shelf life for the product is set. Real time testing is then conducted to further validate the established dating. For the ammonia standards, real-time stability data collection is ongoing.
Value Assignment and Validation: Values are assigned by gravimetric composition. The specified amount of Anhydrous Ammonium Sulfate is accurately weighed on a calibrated analytical balance and dissolved in a Class A volumetric flask with ammonia free deionized water (<1 micromole/Liter).
The values of the standards are confirmed in accordance with the Thermo Trace Ammonia Standard Production Specification document number PS345/00. Each lot of standard is tested with Thermo Trace Ammonia DST reagent, using a previously approved standard lot as a control. Commercially available controls (Roche Preciset NH3) are also included in the verification assay to serve as additional controls on the accuracy of the standard material on an ongoing basis. The product specification #PS3435/00 is also included here for reference.
Instrument Application: Analytical use of the Cobas Mira in testing this product(s) is described in procedure number PS345/00.
Date of Preparation August 23, 2001
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 6 2001
Mr. Thomas Dollar Manager of Regulatory Afffairs Thermo DMA 845 Avenue G East Arlington, TX 76011-7709
K012878 Re:
Trade/Device Name: Thermo Trace Ammonia Standards Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: August 24, 2001 Received: August 28, 2001
Dear Mr. Dollar:
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 for ass sured in the entrebute) 70 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 I ou may, therefore, mains 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 If your device is classinod (too as controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r reaso be actived 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory-Devices · Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A Thermo Electron business 845 Avenue G East Arlington, Texas 76011-7709 USA Telephone 817/607-1700
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO12878
Device Name: Thermo Trace Ammonia Standards Set
Indications For Use: This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Besia Alexander for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012878
/Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
L
(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.