(84 days)
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No
The device description and performance studies focus on the chemical composition and stability of a quality control material for blood gas analyzers, with no mention of AI or ML algorithms.
No
This device is described as a "quality control material" and "aqueous material intended for use to monitor all analytes" on analytical instruments. It is for "In Vitro Diagnostic Use" and helps with "performing periodic QC checks." It does not directly treat or diagnose patients.
No
This device is a quality control material intended to monitor the performance of diagnostic devices, not to diagnose a condition itself.
No
The device description clearly states it is an "aqueous material" and contains "clinically relevant quantities" of various substances, indicating it is a physical liquid control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Purpose: The device is intended to be used as a quality control material for monitoring the performance of various analytes on Bayer instrumentation. This is a typical function of an IVD, ensuring the accuracy and reliability of diagnostic tests performed on patient samples.
- Device Description: The description further clarifies that it's an "aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers." These analyzers are used for in vitro diagnostic testing of patient samples.
Therefore, based on the provided information, the Mission Trinity B Controls are definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mission Trinity B blood gas, electrolyte, metabolite, CO-Oximeter control is an assayed quality control material used for monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Bayer 270/800/400 series) instrumentation for the analytes listed on the Expected Values Chart.
Mission Timity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation.
For In Vitro Diagnostic Use
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Trinity B is a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. Trinity B controls provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC as a part of their quality assurance program.
Trinity B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, chloride, ionized calcium, glucose, lactate and suitable concentrations of dyes to simulate clinically relevant values of hemoglobin, and hemoglobin derivatives: O2Hb, COHb, MetHb and HHB.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted to verify specific performance requirements:
- Accelerated (high temperature) stress test to support stability #
- Side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o demonstrate equivalence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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5. 510(k) Summary
Owner's Name & Address:
Diamond Diagnostics Inc 333 Fiske Street Ho!liston MA 01746 FAX: 508-429-0452
Establishment Registration Number: 3003030793
Date of Preparation: Identification of the Device:
DEC - 1 2006
Contact Person: Randolph Quinn Development & Compliance Manager 508-429-0450 (x318)
September 1, 2006
Proprietary/Trade name: Mission Trinity B Common name blood gas controls with electrolytes, glucose and dyes Classification name: controls for blood-gases (assayed and un-assayed) (Classification # 862.1660, Product Code JJY)
Substantial Equivalence Table of Product Part Numbers & Trade Names
| Diamond/Mission Product | Bayer Equivalent |
|---|---|
| DD-96001 Trinity B Level 1 | 108860 Rapid Complete Level 1 |
| DD-96002 Trinity B Level 2 | 108868 Rapid Complete Level 2 |
| DD-96003 Trinity B Level 3 | 108869 Rapid Complete Level 3 |
| DD-96123 Trinity B Levels 1,2,3 | Not available |
Description of New Device:
Trinity B is a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. Trinity B controls provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC as a part of their quality assurance program.
Trinity B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, chloride, ionized calcium, glucose, lactate and suitable concentrations of dyes to simulate clinically relevant values of hemoglobin, and hemoglobin derivatives: O2Hb, COHb, MetHb and HHB.
Intended Use:
Mission Trinity B blood gas, electrolyte, metabolite, CO-Oximeter control is an assayed quality control material used for monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Bayer 270/800/400 series) instrumentation for the analytes listed on the Expected Values Chart.
Comparison of Technological Characteristics with Predicate Device:
| Characteristics | Mission Trinity B | Bayer Rapid Complete |
|---|---|---|
| PN | DD-96001, 96002, 96003, 96123 | 108860, 108868, 108869 |
| Contents: | ||
| Any Level | Aqueous solution of buffers, electrolytes, glucose, lactate, dyes, equilibrated with CO2, O2 and N2. | |
| Contains NO human or animal materials. | Aqueous solution of buffers, electrolytes, glucose, lactate, dyes, equilibrated with CO2, O2 and N2. | |
| Contains NO human or animal materials. | ||
| Container | Glass ampule (heat sealed, score break) | Glass ampule (heat sealed, score break) |
| Color | Red/purple solution | Red/purple solution |
| Package | 30 X 1.8mL (instrument only requires a fraction a | |
| of an mL to make a measurement) | 30 X 2.5mL | |
| Intended Use | For in-vitro diagnostics use for quality control of | |
| pH/Blood Gas analyzers, ISE analyzers, CO- | ||
| oximeters, and Metabolite analyzers. | For in-vitro diagnostics use for quality control of | |
| pH/Blood Gas analyzers, ISE analyzers, CO- | ||
| oximeters, and Metabolite analyzers. | ||
| Storage / Shelf | ||
| Life | 2-8°C (36-months) or 18-25°C 12-months | 2-8°C or 18-25°C (until expiration date) |
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Assessment of Non-Clinical Performance Data:
Tests were conducted to verify specific performance requirements:
- Accelerated (high temperature) stress test to support stability #
- Side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o demonstrate equivalence
Assessment of Clinical Performance Data:
NA
Conclusions:
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The logo is encircled by text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA'.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Randolph Quinn Development & Compliance Manager Diamond Diagnostics Inc. 333 Fiske Street Holliston, MA 01746
DEC - 1 2006
K062674 Re: Trade/Device Name: Mission Trinity B Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 1, 2006 Received: September 8, 2006
Dear Mr. Quinn:
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 dcvices 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 adultcration.
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).
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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.
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, 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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cc: HFZ-401 DMC
D.O.
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4. Indications for Use Statement
510(k) Number (if known):
K062674
Device Name: Mission Trinity B
Indications For Use:
Mission Timity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation.
For In Vitro Diagnostic Use
Prescription Use _ X (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
vision Sign-Off
Office of In Vitro Diagnostic Device
K 062674
Diamond Diagnostics 510(k) Submission for Trinity B Controls