(74 days)
Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level.
Mission Controls are intended for six systems: AVL Scientific, Ciba-Coming/Bayer, IL, NOVA, Radiometer, Medica, Shapparelli, Medarini.
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas = (pr). pCO2, pO2), and Licolorito - (No, N, Ol, St, L. ( St, S.) = S. ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test . imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
Mission Controls are aqueous based tonometered controls .
Mission uses a similar composition, description and packaging as that used by the predicate Mission uses a similar oompoomon, assistion of this submission.
The provided text describes a 510(k) submission for "Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers" (Mission Controls™). Here's an analysis of the acceptance criteria and study information contained within the submission:
1. A table of acceptance criteria and the reported device performance
The submission mentions "Stability studies were done per SOP23-01-03" and "Stabilities studies support a 3 year shelf life." However, specific quantitative acceptance criteria for performance parameters (e.g., accuracy, precision, bias, stability limits) and the reported numerical device performance results are not provided in the excerpt. The submission focuses on substantial equivalence to a predicate device.
The intended use of the Mission Controls is to "estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation" on pH/Blood Gas and Electrolyte Analyzers. The acceptance criteria would likely be related to the ability of the controls to maintain their specified values within certain limits over their shelf-life and under various storage/use conditions, and to perform comparably to the predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the excerpt. The statement "Stability studies were done per SOP23-01-03" indicates that a study was conducted, but details about the sample size (e.g., number of control lots tested, number of replicates, duration of testing points), data provenance (e.g., where the study was performed), or whether it was retrospective or prospective are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the device is a quality control material for analytical instruments, not a diagnostic device requiring expert interpretation of results to establish "ground truth" in the clinical sense. The "ground truth" for a quality control material is its assigned value, which is determined through a rigorous analytical process, typically by the manufacturer, rather than by human experts in the context of interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for a quality control material for analytical instruments. Adjudication methods are typically used in clinical studies where human interpretation of medical images or data is involved and discrepancies need to be resolved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a quality control material, not an AI-powered diagnostic tool requiring human-in-the-loop assessment or human reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For quality control materials, the "ground truth" is typically established through:
- Assigned Values: These are the expected values of the analytes within the control materials. These values are determined by the manufacturer using highly accurate and precise reference methods, often traceable to international standards, and verified through multiple measurements on various accredited instruments.
- Statistical Analysis: A comprehensive statistical analysis of multiple measurements across different instruments and laboratories is used to establish the mean and range for each analyte within the control. This forms the basis for the control's expected performance and the limits for acceptable variation.
The document implicitly refers to this type of ground truth by stating the controls are used to "estimate test imprecision and to detect systematic deviations." The controls themselves have pre-defined "true" values that analytical instruments are expected to measure within a certain range.
8. The sample size for the training set
This is not applicable. Quality control materials like Mission Controls™ do not involve training sets in the machine learning sense. Their performance is established through analytical validation and stability studies.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
{0}------------------------------------------------
DEC 1 2 2003
Page 25 of 33
510(k) Summary for Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers
| 1. | Submitter's Name & AddressMission Diagnostics331 Fiske StHolliston MA 01746FAX: 508-429-0452 | Contact PersonLinda StundtnerQA/RA Manager508-429-0450 | |
|---|---|---|---|
| Establishment Registration Number: | 3003656721 | ||
| Date of Preparation: | Sept 22, 2003 | ||
| 2. Identification of the Device: | |||
| Proprietary/Trade name: | Mission Controls™ | ||
| Common or usual name | Quality Control material (assay and unassayed) | ||
| Classification name: | Control s for Blood Gases (assay and unassayed) | ||
| Device Classification | I | ||
| Regulation Number: | 21 CFR § 862.1660 | ||
| Panel: | Chemistry (75) | ||
| Product Code: | JJS |
3. Predicate Device:
Substantial Equivalence Table of Product PN's & Trade Names
| Mission Diagnostics | OEM Equivalent | ||||
|---|---|---|---|---|---|
| Predicate Device | Cleared Date | ||||
| DD-92001 | Mission Control Level 1 | A700-001 | ALKOntrol 1 | ||
| DD-92002 | Mission Control Level 2 | A700-002 | ALKtOnrol 2 | K950902 | 03-30-1995 |
| DD-92003 | Mission Control Level 3 | A700-003 | ALKOntrol 3 | ||
| DD-92123 | Mission Control Level 1, 2, 3 | A700-123 | ALKOntrol TriLevel | ||
| DD-92004 | Mission Control Level 4 | A500-004 | ALKOntrol + ™HIGH O₂ |
Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
4. Device Description:
- Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test . imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
- Mission Controls are aqueous based tonometered controls .
Intended Use: .
{1}------------------------------------------------
- intended for for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to . Intended for for profood Gas and Eloother to Analy 2001 instrument or reagent variation.
- Mission uses a similar composition, description and packaging as that used by the predicate � Mission uses a similar oompoomon, assistion of this submission.
5. Performance
- Stability studies were done per SOP23-01-03 .
- Stabilities studies support a 3 year shelf life .
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 2 2003
Diamond Diagnostics, Inc. c/o Ms. Linda M. Stundtner QA/RA Manager Mission Diagnostics 331 Fiske Street Holliston, MA 01746
Re: K033063
Trade/Device Name: Mission Diagnostic ISE pH/Blood Gas Controls for pH/BG &/or Electrolyte Analyzers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJS Dated: September 22, 2003 Received: September 29, 2003
Dear Ms. Stundtner:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{3}------------------------------------------------
Page 2 -
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
- New Indications of use form:
510(k( Number
Device Name: Mission Diagnostic ISE pH/Blood Gas Controls for pH/BG &/or Electrolyte Analyzers
Indication For Use:
- There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical . range for the analytes included in the QC. Level 4 is to check at High O2 level.
- Mission Controls are intended for six systems: .
| AVL Scientific | Ciba-Coming/Bayer | IL | NOVA | Radiometer | Medica, Shapparelli,Medarini |
|---|---|---|---|---|---|
| 945, 947 | 238 | 1304, 1306,1312 | ElectrolyteSystems | ABL 3, 30 | EasyLyte Na/K,Na/K/Cl, Na/K/Li,Na/K/Cl/Li |
| 990, 995 | 248 | BG3 | Stat Profile 1-5 | ABL 300, 330 | |
| Compact Series | 348 | BGE | ABL 5 | ||
| 982, 983, 985 | 278 | 1610, 1620 | ABL, 50, 500,520 | ||
| 986 | 280 | 1630, 1640,1650 | ABL 505 | ||
| 984, 987 | 288 | ABL 600, 610,620 | |||
| OMNI | 664 | EML-100 | |||
| 9110, 9140 | 614, 644 | ||||
| 9120, 9130 | 634 | ||||
| 9180, 9181 | 654 | ||||
| 800 Series |
- The products encompassed by this request are intended for in-vitro diagnostics use and are intended for . The products encompassed by this request are intensed for Ca, Li, TOC2) Analyzers to estimate test pH/Blood Gas = (pr). pCO2, pO2), and Licolorito - (No, N, Ol, St, L. ( St, S.) = S. ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
- The products encompassed are to be handled using normal laboratory precautions. .
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of the Device Evaluation (ODE)
Carol C. Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
/ Prescription use
510(k) K033063
§ 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.