(123 days)
Not Found
No
The device description and performance studies focus on a chemical reaction and electrode measurement, with no mention of AI or ML algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
This device is for in vitro diagnostic use, intended to determine glucose levels for the diagnosis and treatment of conditions like diabetes. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Mission Glucose Reagent is "intended for in vitro diagnostic use for the quantitative determination of glucose" and that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders."
No
The device is a reagent, which is a chemical substance used in a chemical reaction to detect, measure, or produce other substances. It is intended for use with specific hardware systems (Beckman Synchron CX® & CX® Delta Systems) and is not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Mission Glucose Reagent is "intended for in vitro diagnostic use for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF) and urine". This directly aligns with the definition of an IVD, which are medical devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details how the device works to measure glucose in biological samples (serum, plasma, CSF, urine), further confirming its use in a diagnostic context.
- Performance Studies: The document describes performance studies conducted to evaluate the precision and method comparison of the reagent, which are standard practices for validating IVD devices.
- Predicate Device(s): The mention of predicate devices (K numbers and names) indicates that this device is being compared to existing, legally marketed IVD devices.
Therefore, based on the provided information, the Mission Glucose Reagent is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination . Mission Glucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism . Oldoose meader omromo are esellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Product codes
CGA
Device Description
- Glucose concentration is determined by an oxygen rate method employing a Beckman Oxygen . Electrode Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample45
- All CX® & CX® Delta Systems that measure glucose utilize the same measurement method . and reagent.
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . are necessary for the continued operation and use of the instruments.
- The reagent is intended for use on equivalent OEM 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 was collected following the guidelines of NCCLS Guideline EP5-A. Samples were run for 20 days, 2 runs per day, 2 observations per run on an instrument operated according to the manufacturers instructions.
- CSF Control 1: N=80, Mean=59 mg/dL, Swr=0.8, %CV=1.3, ST Total sd=3.8, %CV=6.3
- CSF Control 2: N=80, Mean=30 mg/dL, Swr=1.5, %CV=5.0, ST Total sd=3.0, %CV=10.1
- Serum Control 1: N=80, Mean=89 mg/dL, Swr=2.1, %CV=2.3, ST Total sd=6.0, %CV=6.7
- Serum Control 2: N=80, Mean=308 mg/dL, Swr=2.2, %CV=0.1, ST Total sd=21.7, %CV=7.0
- Urine Control 1: N=80, Mean=45 mg/dL, Swr=1.0, %CV=2.3, ST Total sd=2.3, %CV=5.1
- Urine Control 2: N=80, Mean=287 mg/dL, Swr=2.4, %CV=0.8, ST Total sd=14.4, %CV=5.0
Method Comparison of Mission Glucose Reagent to Beckman Reagent following the guidelines of NCCLS Guideline EP9-A2 was conducted.
- Serum samples (n=50, df=49) were spiked or diluted and run in triplicate. Mission = 1.038 x Beckman - 2.31, Range = 0 to 900 mg/dL; r2 = 0.998; S(vx) = 9.00 mg/dL
- Urine controls (n=57, df=56) were spiked or diluted and run in triplicate. Mission = 1.022 x Beckman + 1.067, Range = 1 to 293 mg/dL; r2 = 0.998; Sq(x) = 2.85 mg/dL
- CSF controls (n=36, df=35) were spiked or diluted and run in triplicate. Mission = 1.014 x Beckman =0.920, Range = 8 to 118 mg/dL; r2 = 0.997; S((x) = 1.68 mg/dL
Recovery to Expected Values was evaluated for each matrix:
- Serum: Mission (Range of average % Recovery: 83.3 - 115.4; Overall Mean Recovery: 103), Beckman (Range of average % Recovery: 83.3 - 117.5; Overall Mean Recovery: 103). Range of Conc. Expected: 30 - 835 mg/dL.
- Urine: Mission (Range of average % Recovery: 88 - 120; Overall Mean Recovery: 101), Beckman (Range of average % Recovery: 87 - 110; Overall Mean Recovery: 97). Range of Conc. Expected: 10 - 300 mg/dL.
- CSF: Mission (Range of average % Recovery: 88 - 98; Overall Mean Recovery: 94), Beckman (Range of average % Recovery: 88 - 100; Overall Mean Recovery: 95). Range of Conc. Expected: 25 - 100 mg/dL.
Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of 42.5 mg/dL, tested as 4 samples per run over 5 calibrated runs. The lowest level where the % CV was less than 20% was with the dilution at an expected value of 9 mg/dL Glucose, which measured/recovered as 10 mg/dL with Mission reagent and 8 mg/dL with Beckman reagent.
- Dilution 1 (Expected 43 mg/dL): Mission Mean 41.9, sd 1.52, %CV 3.6; Beckman Mean 40.5, sd 0.83, %CV 2.0. (N=20)
- Dilution 2 (Expected 14 mg/dL): Mission Mean 14.7, sd 0.75, %CV 5.1; Beckman Mean 13.3, sd 0.64, %CV 4.8. (N=20)
- Dilution 3 (Expected 9 mg/dL): Mission Mean 9.8, sd 0.95, %CV 9.7; Beckman Mean 8.2, sd 0.37, %CV 4.5. (N=20)
- Dilution 4 (Expected 2 mg/dL): Mission Mean 3.6, sd 1.35, %CV 37.6; Beckman Mean 2.1, sd 0.55, %CV 26.3. (N=20)
- Dilution 5 (Expected 0 mg/dL): Mission Mean 2.0, sd 0.65, %CV 32.4; Beckman Mean 0.5, sd 0.51, %CV 113.4. (N=20)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary for Mission Diagnostic Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems
| Mission Diagnostics
331 Fiske St
Holliston MA 01746
FAX: 508-429-0452 | | Linda Stundtn
QA/RA Manag
508-429-0450 |
| -------------------------------------------------------------------------------- | -- | ---------------------------------------------- |
|---|
| Establishment Registration Number: | 3003656721 |
|---|---|
| Date of Preparation: | Jan 16, 2004 |
- Identification of the Device:
| Proprietary/Trade name: | Glucose Reagent for Beckman Synchron
CX® & CX® Delta Systems |
|-------------------------|-----------------------------------------------------------------|
| Common or usual name | Glucose Reagent |
| Classification name: | Glucose test system |
| Device Classification | II |
Mission manufactures reagents intended to serve as direct replacements to like named products . manufactured by Original Equipment Manufactures (OEM)
21 CFR § 862.1345
Chemistry (75)
3. Predicate Device:
Panel:
Regulation Number:
Product Code:
- Mission claims substantial equivalence to the OEM Reagent listed below: .
CGA
Substantial Equivalence Table of Product PN & Trade Names
| Mission Product | OEM Equivalent | ||
|---|---|---|---|
| BK-443355D | Glucose Reagent | 443355 | Glucose Reagent |
- The predicate reagent, Beckman PN 443355, is encompassed in the 510(k)'s K942676 & ● K864236 cleared 11/02/1994 & 12/31/1986 respectively.
4. Device Description:
- Glucose concentration is determined by an oxygen rate method employing a Beckman Oxygen . Electrode Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample45
Intended Use:
- Mission Glucose Reagent is intended for the quantitative determination of glucose in serum, . plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate . metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
133055
Contact Person:
Linda Stundtner anager 0450
JAN S 0 2004
Submitter's Name & Address
1
- All CX® & CX® Delta Systems that measure glucose utilize the same measurement method . and reagent.
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . are necessary for the continued operation and use of the instruments.
- The reagent is intended for use on equivalent OEM 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 .
Precison and Correlation are summarized below:
Precision data was collected following the guidelines of NCCLS Guideline EP5-A
- Samples were run for 20 days, 2 runs per day, 2 observations per run on an instrument . operated according to the manufacturers instructions. The following data was obtained:
| | N | Test
Mean
mg/dL | Swr
within
run sd | % CV | ST
Total
sd | %CV |
|-----------------|----|-----------------------|-------------------------|------|-------------------|------|
| CSF Control 1 | 80 | 59 | 0.8 | 1.3 | 3.8 | 6.3 |
| CSF Control 2 | 80 | 30 | 1.5 | 5.0 | 3.0 | 10.1 |
| Serum Control 1 | 80 | 89 | 2.1 | 2.3 | 6.0 | 6.7 |
| Serum Control 2 | 80 | 308 | 2.2 | 0.1 | 21.7 | 7.0 |
| Urine Control 1 | 80 | 45 | 1.0 | 2.3 | 2.3 | 5.1 |
| Urine Control 2 | 80 | 287 | 2.4 | 0.8 | 14.4 | 5.0 |
Method Comparison of Mission Glucose Reagent to Beckman Reagent following the guidelines of NCCLS Guideline EP9-A2 was conducted.
Serum samples were spiked or diluted and run in triplicate and tested with each reagent, Mission Glucose Reagent and Beckman Glucose Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:
Mission = 1.038 x Beckman - 2.31 Range = 0 to 900 mg/dL; r2 = 0.998; df = 49; n = 50; S(vx) = 9.00 mg/dL
Urine controls were spiked or diluted and run in triplicate and tested with each reagent, Mission Glucose Reagent and Beckman Glucose Reagent in separate calibrated runs. Recoveries were compared by least squares regression. The following statistics were obtained:
Mission = 1.022 x Beckman + 1.067 Range = 1 to 293 mg/dL; r2 = 0.998; df = 56; n = 57; Sq(x) = 2.85 mg/dL
CSF controls were spiked or diluted and run in triplicate and tested with each reagent, Mission Glucose Reagent and Beckman Glucose Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:
Mission = 1.014 x Beckman =0.920 Range = 8 to 118 mg/dL; r2 = 0.997; df = 35; n = 36; S((x) = 1.68 mg/dL
2
Recovery to Expected Values was evaluated for each matrix; serum, urine and CSF. Dilutions of the respective matrices were made and measured with Mission and Beckman reagent.
- Pooled Serum was spiked to an expected value of 950 mg/dL by adding glucose gravimetrically. . Dilutions were made using the spiked serum, serum, and/or Human serum albumin (HmSA).
- Urine recovery samples were made by mixing Urine Control 2 (expected value = 300 mg/dL), Urine . Control 1 (expected value = 50 mg/dL), and/or Normal saline.
- CSF recovery samples were made by mixing CSF Control 2 (expected value = 100 mg/dL), CSF . Control 1 (expected value = 50 mg/dL), and/or Human Serum Albumin.
% Recovery = (Measured/expected) x100 was calculated for both Mission and Beckman. Mission and Beckman exhibited similar recoveries across the range of values in all matrices. See table below:
| Matrix | Range of Conc.
Expected, mg/dL | Reagent | Range of average %
Recovery | Overall Mean
Recovery |
|--------|-----------------------------------|---------|--------------------------------|--------------------------|
| Serum | 835 - 30 mg/dL | Mission | 83.3 - 115.4 | 103 |
| Serum | 835 - 30 mg/dL | Beckman | 83.3 - 117.5 | 103 |
| Urine | 300 - 10 mg/dL | Mission | 88 - 120 | 101 |
| Urine | 300 - 10 mg/dL | Beckman | 87 - 110 | 97 |
| CSF | 100 - 25mg/dL | Mission | 88 - 98 | 94 |
| CSF | 100 - 25mg/dL | Beckman | 88 - 100 | 95 |
Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of an approximately concentration of 42.5 mg/dL; and dilutions of 1:3, 1:5.1:11 and a zero. Dilutions were tested as 4 samples per run over 5 calibrated runs.
- The lowest level where the % CV was less than 20% was with the dilution at an expected . value of 9 mg/dL Glucose which measured/recovered as:
- 10 mg/dL with Mission reagent .
- . 8 mg/dL with Beckman reagent.
The CX Delta reports Glucose values to the whole number.
| Dilution | Expected value mg/dL | Mission Reagent | Beckman Reagent | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | sd | N | %CV | Mean | sd | N | %CV | ||
| 1 | 43 | 41.9 | 1.52 | 20 | 3.6 | 40.5 | 0.83 | 20 | 2.0 |
| 2 | 14 | 14.7 | 0.75 | 20 | 5.1 | 13.3 | 0.64 | 20 | 4.8 |
| 3 | 9 | 9.8 | 0.95 | 20 | 9.7 | 8.2 | 0.37 | 20 | 4.5 |
| 4 | 2 | 3.6 | 1.35 | 20 | 37.6 | 2.1 | 0.55 | 20 | 26.3 |
| 5 | 0 | 2.0 | 0.65 | 20 | 32.4 | 0.5 | 0.51 | 20 | 113.4 |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes extending from its body, representing health and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the logo.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 5 0 2004
Ms. Linda M. Stundtner OA/RA Manager Diamond Diagnostics Mission Diagnostics Division 331 Fiske St. Holliston. MA 01746
K033055 Re:
Trade/Device Name: Mission Diagnostic Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: December 22, 2003 Received: December 24, 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 for use based in 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, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, allere, mass 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 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 I least be devilsed that I Dr bration that your device complies with other requirements of the Act that I Dri has made a aoved regulations administered by other Federal agencies. You must or any I ederal banales and states and mot 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).
4
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,
Jean M. Cooper, MS, DVM.
MC, MS DVM
Yean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Mission Diagnostic Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems
Indications For Use:
- Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination . Mission Glucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism . Oldoose meader omromo are esellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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. Benam for Jean Cooper. NM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033055
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