Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use describe a quality control material for laboratory analyzers, not a device that processes data or makes decisions using AI/ML. There is no mention of AI, ML, or related concepts in the provided text.

Therapeutic

No
The device is described as an in vitro diagnostic quality control material used for monitoring the precision and performance of analyzers, not for treating any medical condition.

Diagnostic

No
This device is a quality control material intended to monitor the precision and performance of other analyzers. It is used to ensure the accuracy of diagnostic devices, rather than being a diagnostic device itself that directly diagnoses a patient's condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a buffered solution packaged in glass ampules, which are physical components, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "It is for in vitro diagnostics use".

Furthermore, the device is a quality control material used to monitor the performance of instruments that measure analytes in blood, which is a biological sample. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Mission Trinity R TM Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.

Product codes

JJY

Device Description

Trinity R matrix consists of a buffered solution of electrolytes, glucose, lactate, dyes and preservative. It is equilibrated with specific levels of CO2, O2, and N2. It contains no human or biological materials. Trinity R is provided in three (3) distinct levels of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, % HbO2Sat, %COHb, %MetHb, %O2Ct & %HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules of each level).

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K880447

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

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MAR 1 0 2010

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் 510(k) Summary

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

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| The Assigned 510(k) Number is: K093384
Applicant: | Diamond Diagnostics, Inc.
333 Fiske Street
Holliston, MA 01746 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Kathy Cruz
Qaulity Assurance Manager
Phone: (508) 429-0450 ext. 358
Fax: (508) 429-0452 |
| Date Prepared: | March 4, 2010 |
| Controls: | |
| Classification Name: | Controls for blood-gases (Assayed and Un-Assayed) |
| Trade Name: | Mission Trinity R |
| Device Classification: | 21 CFR 862.1660 |
| Device Class: | Class I |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JJY |

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| Intended Use: | Mission Trinity R TM Control is intended to be used as an assayed quality control
material for monitoring the precision and performance of the following analytes pH, pCO2,
pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite
analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-
Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative
determination of the analytes listed on the Expected Values Chart. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | Trinity R matrix consists of a buffered solution of electrolytes, glucose, lactate, dyes and
preservative. It is equilibrated with specific levels of CO2, O2, and N2. It contains no
human or biological materials. Trinity R is provided in three (3) distinct levels of pH,
pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, % HbO2Sat, %COHb,
%MetHb, %O2Ct & %HHb covering the significant range of the instrument performance. It
is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are
packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules
of each level). |
| Predicate Device name: | RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-OXimeter (Radiometer)
Control |
| Predicate 510(k) number(s): | K880447 |

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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Comparison with predicate:

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Similarities
Characteristics	Mission Trinity R	RNA Medical RA 525 Blood Gas,
Electrolyte, Metabolite, CO-OXimeter
(Radiometer)
510(K) Number	K093384	K880447
Product Type	Assayed Blood Gas Control	Assayed Blood Gas Control
Intended Use	For in vitro diagnostics use for quality control
of pH/Blood Gas analyzers, ISE analyzers,
Metabolite analyzers and CO-OXimeter
Instrumentation.	Same
Matrix	Buffered Aqueous Solution	Same
Storage	2-8°C	Same
Color	Red/purple solution	Same
Levels	Three	Same
Analytes	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,
lactate, tHb, %O2Hb, %COHb, %metHb,
%O2Ct, %O2Sat and %HHb	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,
lactate, tHb, %O2Hb, %COHb, %metHb,
%O2Ct, %O2Sat and %HHb

Differences
Characteristics	Mission Trinity R	RNA Medical RA 525 Blood Gas,
Electrolyte, Metabolite, CO-OXimeter
(Radiometer)
Preservative	Present	Not present
Package	30 X 1.8mL	30 X 2.5mL
Shelf Life	24 months	36 months

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Mission claims substantial equivalence to RNA Medical RA525 Controls listed below:

Substantial Equivalence Table of Product PN's & Trade Names

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Mission Product		RNA Medical RA 525
DD-97001D	Mission Trinity R Control (Level 1)	RA 525-1	RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Level 1)
DD-97002D	Mission Trinity R Control (Level 2)	RA 525-2	RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Level 2)
DD-97003D	Mission Trinity R Control (Level 3)	RA 525-3	RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Level 3)
DD-97123	Mission Trinity R Control (Multi-Level)	RA 525	RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (Multi-Level)

Mission claims substantial equivalence to RNA Medical RA525 for Composition, Intended use, Packaging, Storage, and Shelf life.

The tables below compare Mission to RNA Medical RA525.

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Comparison Tables of Characteristics - Mission vs RNA Medical - by product

| Characteristics | Mission Trinity R | RNA Medical RA 525 Blood Gas,
Electrolyte, Metabolite, CO-OXimeter
(Radiometer) K880447 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Type | Assayed Blood Gas Control | Assayed Blood Gas Control |
| Intended Use | For in vitro diagnostics use for quality control
of pH/Blood Gas analyzers, ISE analyzers,
Metabolite analyzers and CO-OXimeter
Instrumentation. | For in vitro diagnostics use for quality
control of pH/Blood Gas analyzers, ISE
analyzers, Metabolite analyzers and CO-
Oximeter Instrumentation. |
| Matrix | Buffered Aqueous Solution | Buffered Aqueous Solution |
| Storage | 2-8°C | 2-8°C |
| Color | Red/purple solution | Red/purple solution |
| Levels | 1, 2, 3 | 1, 2, 3 |
| Analytes | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,
lactate, tHb, %O2Hb, %COHb, %metHb,
%O2Ct, %O2Sat and %HHb | pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,
lactate, tHb, %O2Hb, %COHb, %metHb,
%O2Ct, %O2Sat and %HHb |
| Preservative | Present | Not present |
| Package | 30 X 1.8mL | 30 X 2.5mL |
| Shelf Life | 24 months | 36 months |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Diamond Diagnostics Inc. c/o Kathy Cruz 333 Fiske Street Holliston, Massachusetts 01746

MAR 1 0 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: K093384

Trade Name: Mission Trinity R Blood Gas Controls Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Assayed and Unassayed. Regulatory Class: Class I, reserved Product Codes: JJY Dated: January 4, 2010 Received: January 4, 2010

Dear Ms. Cruz:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cfa

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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. Indications for Use 510(k) Number (if known): K093384

Device Name: __ Mission Trinity R_

Indications for Use:

Mission Trinity R™ Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na*, K*, Ca**, Cn, glucose, and lactate on blood gas,
electrolyte, and metabolite analyzers as well as tHb, %OJ-Kb, Oximeter instrumentation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) -

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093384

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