(72 days)
Not Found
No
The summary describes a device that uses aqueous reagents and salts for calibration in an in-vitro diagnostics setting. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on precision and correlation of chemical measurements, not algorithmic performance.
No
Explanation: The device is intended for in-vitro diagnostics use, specifically for calibrating electrodes in laboratory settings, not for treating diseases or health conditions.
No.
The device itself is a calibrator/reagent pack for an in-vitro diagnostic instrument, not the diagnostic instrument itself. Both the "Intended Use" and "Device Description" sections explicitly state it is for "calibrating the electrodes" and contains "calibrating and wash reagents".
No
The device description clearly states it is a "self-contained closed reagent package containing all the calibrating and wash reagents" and "aqueous reagents with salts (chemical constituents) added". This describes a physical product containing chemical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The products encompassed by this request are intended for in-vitro diagnostics use..."
- Function: The device is described as "calibrating the electrodes" for instruments that measure analytes (Na, K, Cl, Ca, Li) in human serum samples. Calibration is a crucial step in ensuring the accuracy of in-vitro diagnostic tests.
- Context: The performance studies involve analyzing control materials and human serum samples, which are typical activities in an in-vitro diagnostic setting.
- Predicate Device: The predicate device listed (K963763) is an "Electrode, ion-specific," which is a component used in in-vitro diagnostic analyzers.
Therefore, based on the provided information, the Mission Fluid Packs are clearly intended and used as part of an in-vitro diagnostic process.
N/A
Intended Use / Indications for Use
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes.
Mission reagents are intended to serve as direct replacements to like named products. manufactured by the OEM.
The products encompassed are to be handled using normal laboratory precautions.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Mission Fluid Packs (PN = ME-XXXXD or IL-XXXXD or MN-XXXXD) are . equivalent to the Medica EasyLyte Solutions Packs or IL Test™ Solutions Packs or Menarinin Spotlyte™ Packs. They are a self-contained closed reagent package containing all the calibrating and wash reagents. The Solutions Packs slide into the front of the instrument for operation.
The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) added to obtain desired analyte levels to provide the desired calibration.
The reagents are intended for use in place of predicate devices.
The original equipment manufacturer (OEM) of the instruments and the predicate reagents . which are necessary for the continued operation and use of the instruments.
Mission uses a similar composition, description and packaging as that used by the OEM in its . products, as shown in the packaging section of this submission.
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)
Precision data were collected from the analysis of three levels of control materials during a minimum of two runs per day on the Medica analyzers calibrated with all Mission reagents and when calibrated with Medica reagents.
Data shows that QC precision with Mission Fluid Packs was substantially equivalent to the QC precision with Medica Fluid Packs.
Correlation data were obtained from human serum samples for Na, K, Cl, Ca, and Li. Samples were then spiked to vield varying concentrations of each of the measuring analytes. The serum samples were measured on Medica EasyLytes calibrated with Mission Fluid Packs for 2 runs and Calibrated with Medica Fluid Packs for 2 runs each test day.
Linear regression analysis was performed using Mission data as the independent X variable and Medica as the dependent Y variable in the equation Y = mX +b where m = slope, b = intercept.
Correlation with Medica Fluid Packs
| Analyte | N | Slope | Intercept | R2 | Range |
|---|---|---|---|---|---|
| Na | 55 | 1.0 | 5.2 | 0.99 | 35.4 - 193.8 |
| K | 55 | 1.0 | 0.03 | 1.00 | 1.80 - 8.61 |
| Cl | 55 | 1.0 | 4.6 | 1.00 | 21.4 - 192.1 |
| Li | 15 | 0.9 | 0.09 | 1.00 | 0.73 - 1.96 |
Mission Fluid Packs are substantially equivalent to Medica Fluid Packs. The Correlations exhibited slopes of 1 and R2 of 1.00 to 0.99.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
JUN 2 2 2003
16031159
510(k) Summary for Mission Diagnostic Fluid Packs on MEDICA Electrolyte Analyzers
| 1. Submitter's Name & Address | Mission Diagnostics
331 Fiske St
Holliston MA 01746
FAX: 508-429-0452 |
|------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Linda Stundtner
QA/RA Manager
508-429-0450 |
| Establishment Registration Number: | 3003656721 |
| Date of Preparation: | April 11, 2003 |
| 2. Identification of the Device: | |
| Proprietary/Trade name: | Calibrating Material, Calibrating standards |
| Common or usual name | Calibrator Pack, Fluid Pack for ISE automated systems |
| Classification name: | Calibrator, secondary |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1150 |
| Panel: | Chemistry (75) |
JIT
- Mission manufactures calibrators intended to serve as direct replacements to like named products manufactured by Original Equipment Manufactures (OEM)
3. Predicate Device:
Product Code:
- Mission claims substantial equivalence to the predicate device, Electrode, ion-specific, sodium; . EasyLyte Na,K,Cl, Li Analyzer; K963763, MEDICA CORP.
1
| Mission Product | Predicate Device | ||
|---|---|---|---|
| ME-2120D & | |||
| ME-2109D | Medica 800 & 400 ml Fluid Packs | ||
| Na/K | 2120 & | ||
| 2109 | Medica EasyLyte 800 & 400 ml Solutions Pack | ||
| Na/K | |||
| ME-2121D & | |||
| ME-2112D | Medica 800 & 400 ml Fluid Packs | ||
| Na/K/Cl | 2121 & | ||
| 2112 | Medica EasyLyte 800 & 400 ml Solutions Pack | ||
| Na/K/Cl | |||
| ME-2122D & | |||
| ME-2115D | Medica 800 & 400 ml Fluid Packs | ||
| Na/K/Li | 2122 & | ||
| 2115 | Medica EasyLyte 800 & 400 ml Solutions Pack | ||
| Na/K/Li | |||
| ME-2123D & | |||
| ME-2114D | Medica 800 & 400 ml Fluid Packs | ||
| Na/K/Ca/pH | 2123 & | ||
| 2114 | Medica EasyLyte 800 & 400 ml Solutions Pack | ||
| Na/K/Ca/pH | |||
| ME-2026D & | |||
| ME-2028D | Medica 800 & 400 ml Fluid Packs | ||
| Na/K/Cl/Li | 2026 & | ||
| 2028 | Medica EasyLyte 800 & 400 ml Solutions Pack | ||
| Na/K/Cl/Li | |||
| IL-2120D | ILyte 800 Fluid Pack Na/K | ME002120 | IL Test™ 800 Solutions Pack |
| Na/K | |||
| IL-2121D | ILyte 800 Fluid Pack Na/K/Cl | ME002121 | IL Test™ 800 Solutions Pack |
| Na/K/Cl | |||
| IL-2120D | ILyte 800 Fluid Pack Na/K/Li | ME002122 | IL Test™ 800 Solutions Pack |
| Na/K/Li | |||
| IL-2123D | ILyte Fluid Pak Na/K/Ca/pH | ME002123 | IL Test™ 800 Solutions Pack |
| Na/K/Ca/pH | |||
| IL-2026D | ILyte 800 Fluid Pack Na/K/Cl/Li | ME002026 | IL Test™ 800 Solutions Pack |
| Na/K/Cl/Li | |||
| MN-2120D | Menarini 800 Fluid Pack Na/K | Not Known | Spotlyte™ 800 Solutions Pack |
| Na/K | |||
| MN-2121D | Menarini 800 Fluid Pack Na/K/Cl | Not Known | Spotlyte™ 800 Solutions Pack |
| Na/K/Cl | |||
| MN-2120D | Menarini 800 Fluid Pack Na/K/Li | Not Known | Spotlyte™ 800 Solutions Pack |
| Na/K/Li | |||
| MN-2123D | Menarini Fluid Pak Na/K/Ca/pH | Not Known | Spotlyte™ 800 Solutions Pack Na/K/Ca/pH |
| MN-2026D | Menarini 800 Fluid Pack Na/K/Cl/Li | Not Known | Spotlyte™ 800 Solutions Pack Na/K/Cl/Li |
Substantial Equivalence Table of Product PN's & Trade Names
- The Mission Fluid Packs (PN = ME-XXXXD or IL-XXXXD or MN-XXXXD) are . equivalent to the Medica EasyLyte Solutions Packs or IL Test™ Solutions Packs or Menarinin Spotlyte™ Packs. They are a self-contained closed reagent package containing all the calibrating and wash reagents. The Solutions Packs slide into the front of the instrument for operation.
4. Device Description:
- . The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) added to obtain desired analyte levels to provide the desired calibration.
. Intended Use:
- . The reagents are intended for use in place of predicate devices.
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . which are necessary for the continued operation and use of the instruments.
- Mission uses a similar composition, description and packaging as that used by the OEM in its . products, as shown in the packaging section of this submission.
5. Performance Characteristics:
Precision and correlation data are collected per:
- SOP23-01-02 Performance Study Protocol for 510(K) Submission t
- Data for each instrument and each run are recorded on SOP23-03F Performance Study t Record Sheet. (See Attachment Section for Copy of Procedures)
510(k) Submission for Mission Diagnostics Reagents on Electrolyte Analyzers
2
Precision Data
Precision data were collected from the analysis of three levels of control materials during a minimum of two runs per day on the Medica analyzers calibrated with all Mission reagents and when calibrated with Medica reagents.
Data shows that QC precision with Mission Fluid Packs was substantially equivalent to the QC precision with Medica Fluid Packs.
| Analyte | Level | N | Mean | sd | Min | Max | %CV |
|---|---|---|---|---|---|---|---|
| Na | 1 | 12 | 115.1 | 3.0 | 110.0 | 121.1 | 2.6 |
| 2 | 12 | 135.6 | 1.2 | 133.0 | 138.0 | 0.9 | |
| 3 | 12 | 159.6 | 2.8 | 156.0 | 166.0 | 1.8 | |
| K | 1 | 12 | 2.05 | 0.07 | 1.97 | 2.19 | 3.5 |
| 2 | 12 | 4.21 | 0.02 | 4.17 | 4.24 | 0.5 | |
| 3 | 12 | 6.63 | 0.05 | 6.48 | 6.69 | 0.8 | |
| Cl | 1 | 12 | 72.3 | 2.6 | 67.9 | 77.0 | 3.6 |
| 2 | 12 | 91.4 | 3.3 | 82.0 | 96.0 | 3.6 | |
| 3 | 12 | 114.3 | 4.9 | 102.0 | 118.0 | 4.3 | |
| Li | 1 | 12 | 0.32 | 0.09 | 0.22 | 0.49 | |
| 2 | 12 | 1.10 | 0.01 | 1.09 | 1.12 | ||
| 3 | 12 | 2.25 | 0.14 | 1.98 | 2.38 |
MEDICA Precision Data w/ MISSION REAGENTS
MEDICA Precision Data w/ MEDICA REAGENTS
| Analyte | Level | N | Mean | sd | Min | Max | %CV |
|---|---|---|---|---|---|---|---|
| Na | 1 | 12 | 116.4 | 5.4 | 106.0 | 128.0 | 4.6 |
| 2 | 12 | 136.8 | 3.5 | 131.0 | 142.0 | 2.5 | |
| 3 | 12 | 159.9 | 2.9 | 155.0 | 165.0 | 1.8 | |
| K | 1 | 12 | 2.06 | 0.06 | 1.96 | 2.19 | 2.9 |
| 2 | 12 | 4.23 | 0.02 | 4.19 | 4.26 | 0.5 | |
| 3 | 12 | 6.68 | 0.07 | 6.54 | 6.79 | 1.1 | |
| Cl | 1 | 12 | 72.5 | 5.3 | 58.0 | 77.0 | 7.3 |
| 2 | 12 | 91.6 | 6.0 | 73.0 | 97.0 | 6.5 | |
| 3 | 12 | 117.9 | 6.8 | 106.0 | 137.0 | 5.7 | |
| Li | 1 | 12 | 0.34 | 0.08 | 0.26 | 0.32 | |
| 2 | 12 | 1.12 | 0.01 | 1.10 | 1.12 | ||
| 3 | 12 | 2.17 | 0.09 | 2.15 | 2.29 |
3
Correlation with Medica Fluid Packs
Correlation data were obtained from human serum samples for Na, K, Cl, Ca, and Li. Samples were then spiked to vield varying concentrations of each of the measuring analytes. The serum samples were measured on Medica EasyLytes calibrated with Mission Fluid Packs for 2 runs and Calibrated with Medica Fluid Packs for 2 runs each test day.
Linear regression analysis was performed using Mission data as the independent X variable and Medica as the dependent Y variable in the equation Y = mX +b where m = slope, b = intercept
| Analyte | N | Slope | Intercept | R2 | Range |
|---|---|---|---|---|---|
| Na | 55 | 1.0 | 5.2 | 0.99 | 35.4 - 193.8 |
| K | 55 | 1.0 | 0.03 | 1.00 | 1.80 - 8.61 |
| Cl | 55 | 1.0 | 4.6 | 1.00 | 21.4 - 192.1 |
| Li | 15 | 0.9 | 0.09 | 1.00 | 0.73 - 1.96 |
MEDICA Correlation Summary
Mission Fluid Packs are substantially equivalent to Medica Fluid Packs. The Correlations exhibited slopes of 1 and R2 of 1.00 to 0.99.
4
Image /page/4/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 three human profiles connected by flowing lines, resembling a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2003
Diamond Diagnostics, Inc. c/o Ms. Linda M. Stundtner Mission Diagnostics 331 Fiske Street Holliston, MA 01746
Re: K031159
Trade/Device Name: Mission Diagnostic Fluid Packs on MEDICA Electrolyte Analyzers Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 11, 2003 Received: May 27, 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. Iisting 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).
5
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
6
Page 36 of 49
510(k( Number K031159
Device Name: Mission Diagnostic Fluid Packs on MEDICA Electrolyte Analyzers
Indication For Use:
- The products encompassed by this request are intended for in-vitro diagnostics use and are ● intended for use in calibrating the electrodes.
- Mission reagents are intended to serve as direct replacements to like named products . manufactured by the OEM.
- 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)
Division Sign-Off
(Optional format 3-10-98)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k031/5-9
Prescription Use X