THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609

K012878 · Thermo Dma, Inc. · JIS · Oct 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012878
• Device Name: THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
• Applicant: Thermo Dma, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Oct 16, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended 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.

Device Story

Thermo Trace Ammonia Standards Set consists of aqueous solutions of Ammonium Sulfate and Sodium Azide preservative. Used as a calibrator for in vitro diagnostic determination of ammonia in human plasma. Operates by establishing reference points for the Thermo Trace Ammonia Reagent (K974620). Values are assigned via gravimetric composition using anhydrous ammonium sulfate dissolved in ammonia-free deionized water. Product is intended for clinical laboratory use. Healthcare providers use the output to calibrate ammonia assays, ensuring accuracy in patient plasma ammonia measurements, which aids in diagnosing and monitoring conditions related to ammonia metabolism.

Clinical Evidence

Bench testing only. Stability determined via accelerated stress testing at multiple temperatures. Value assignment performed by gravimetric composition and verified against previously approved standard lots and commercially available controls (Roche Preciset NH3).

Technological Characteristics

Aqueous solution of Ammonium Sulfate and Sodium Azide preservative. Prepared using ammonia-free deionized water (<1 micromole/Liter). Value assignment via gravimetric composition using analytical balance and Class A volumetric glassware. No software or electronic components.

Indications for Use

Indicated for use as a calibrator to establish reference points for the determination of ammonia levels in human plasma samples.

Regulatory Classification

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.)

Special Controls

*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.

Reference Devices

• Thermo Trace Ammonia Reagent (K974620)
• Roche Preciset NH3

Submission Summary (Full Text)

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## Thermo DMA

845 Avenue G East Arlington, TX 76011-7709

510 (k) Summary

[phone] Fax: [phone] 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 [phone]

## 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)

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(Optional Format 1-2-96)