(49 days)
Not Found
No
The device description and performance studies focus on chemical reagents and their stability, with no mention of AI or ML technologies.
No
The device is described as a reagent and standard solution used for in vitro diagnostic testing to determine ammonia levels in human plasma. It does not directly provide therapy or treatment to a patient.
Yes
Explanation: The device description explicitly states, "The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use." The product helps establish points of reference for determining ammonia in human plasma, which is a diagnostic activity.
No
The device is a reagent, which is a chemical substance used in a laboratory test, not a software program. The description clearly states it is an "aqueous solution" and mentions chemical components like Ammonium Sulfate and Sodium Azide.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says, "This reagent is intended for use with Thermo Trace Ammonia Reagent... to establish points of reference that are used in the determination of Ammonia in human plasma." Determining a substance in human plasma is a diagnostic test performed in vitro (outside the body).
- Device Description: The description reiterates, "The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent... to establish points of reference that are used in the determination of Ammonia in human plasma." The phrase "in vitro diagnostic use" is a direct indicator.
The device is a standard used in a diagnostic test, making it an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JIS
Device Description
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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 (
§ 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
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 (