(39 days)
Not Found
No
The document describes standard in-vitro diagnostic reagents for calibrating electrodes and does not mention any AI or ML components.
No
The device is described as being for "in-vitro diagnostics use" and is a "reagent" for the "calibration of the ISE electrodes". It does not directly treat or diagnose a disease state in a patient, which is the definition of a therapeutic device.
Yes
The product's intended use explicitly states "intended for in-vitro diagnostics use." While it serves as a reagent for calibration, calibration fall under the broader umbrella of ensuring the accuracy and reliability of diagnostic tests.
No
The device description clearly states the device is an "aqueous reagent with salts added," indicating it is a chemical substance, not software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The three products encompassed by this request are intended for in-vitro diagnostics use."
- Function: The products are described as reagents used for the calibration of electrodes on laboratory instruments (analyzers) to measure analytes (Na, K, Cl, Ca, TCO2) in biological samples (Serum, CSF, Urine). This is a core function of in-vitro diagnostics.
- Laboratory Setting: The text mentions "normal laboratory precautions" and testing being performed on laboratory instruments (CX Delta and CX).
- Performance Studies: The description of performance studies involving method comparison and analysis of precision and correlation are typical for IVD devices to demonstrate their analytical performance.
Therefore, the intended use, function, and context of use all strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The three products encompassed by this request are intended for in-vitro diagnostics use.
Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2.
The CO2 Acid reagent is used to release CO2 from samples.
The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode.
Mission reagents are intended to serve as direct replacements to the predicate devices 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, JIX
Device Description
The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes.
The reagents are 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.
Mission Product:
BK-443320D CO2 Alkaline Buffer
BK-443330D CO2 Acid
BK-450214D ISE Electrolyte Reference
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance equivalence is shown through a method comparison where results obtained on an equivalent OEM analyzer, calibrated with Mission calibrating material are compared with results obtained on the same analyzer calibrated with OEM calibrating material.
Precision and correlation data are collected per:
SOP23-01-02 Performance Study Protocol for 510(k) Submission
Data for each instrument and each run are recorded on SOP23-03F Performance Study Record Sheet.
All analytes tested passed criteria per SOP23-01-02 Performance Study Protocol for 510(k) Submission and performed equally to the OEM.
Testing was performed on CX® Delta and CX® depending on availability.
Precision of Serum Controls, CSF Controls & Urine Controls on CX® Delta:
Na mmol/L: DCtrol 1 (N=43, Mean=142.0, Sd=6.4, Min=129.6, Max=157.0, %CV=4.5); DCtrol 2 (N=38, Mean=155.7, Sd=6.9, Min=148.7, Max=174.4, %CV=4.4); CSF 1 (N=13, Mean=127.4, Sd=6, Min=119.4, Max=139.0, %CV=3.8); CSF 2 (N=12, Mean=159.9, Sd=5, Min=153.8, Max=170.3, %CV=4.9); URINE 1 (N=48, Mean=65.6, Sd=4.9, Min=59.7, Max=77.0, %CV=7.5); URINE 2 (N=44, Mean=208.2, Sd=7.9, Min=197.1, Max=227.8, %CV=3.8).
K mmol/L: DCtrol 1 (N=43, Mean=4.22, Sd=0.22, Min=3.88, Max=4.71, %CV=5.10); DCtrol 2 (N=45, Mean=8.10, Sd=0.37, Min=7.69, Max=9.21, %CV=4.59); URINE 1 (N=48, Mean=33.7, Sd=2.2, Min=31.5, Max=39.0, %CV=6.4); URINE 2 (N=45, Mean=108.4, Sd=6.1, Min=101.4, Max=122.9, %CV=5.6).
Cl mmol/L: DCtrol 1 (N=43, Mean=107, Sd=5, Min=98, Max=118, %CV=4); DCtrol 2 (N=38, Mean=118, Sd=5, Min=113, Max=131, %CV=4); CSF 1 (N=13, Mean=89, Sd=4, Min=84, Max=95, %CV=4); CSF 2 (N=12, Mean=105, Sd=3, Min=102, Max=111, %CV=3); URINE 1 (N=47, Mean=100, Sd=6, Min=92, Max=113, %CV=6); URINE 2 (N=47, Mean=256, Sd=10, Min=245, Max=280, %CV=4).
Ca mmol/L: DCtrol 1 (N=31, Mean=2.51, Sd=0.08, Min=2.39, Max=2.69, %CV=3.06); DCtrol 2 (N=27, Mean=3.35, Sd=0.18, Min=3.16, Max=4.00, %CV=5.23); URINE 1 (N=29, Mean=1.57, Sd=0.14, Min=1.44, Max=1.90, %CV=8.97); URINE 2 (N=32, Mean=3.50, Sd=0.14, Min=3.27, Max=3.84, %CV=3.99).
CO2 mmol/L: DCtrol 1 (N=40, Mean=14.8, Sd=0.7, Min=13.1, Max=16.0, %CV=4.4); DCtrol 2 (N=43, Mean=25.4, Sd=1.1, Min=23.1, Max=28.2, %CV=4.2).
Precision of Serum Samples on CX® Delta:
Ca mmol/L: Normal (N=18, Mean=2.42, Sd=0.06, Min=2.30, Max=2.52, %CV=2.5); Lo (N=18, Mean=1.96, Sd=0.06, Min=1.86, Max=2.05, %CV=3.1); High (N=18, Mean=3.65, Sd=0.13, Min=3.47, Max=3.84, %CV=3.6).
Precision of Serum Controls on CX®:
Na mmol/L: DCtrol 1 (N=18, Mean=139.7, Sd=0.08, Min=138.5, Max=141.1, %CV=0.6); DCtrol 2 (N=18, Mean=154.1, Sd=1.03, Min=152.6, Max=156.0, %CV=0.7).
K mmol/L: DCtrol 1 (N=14, Mean=4.07, Sd=0.01, Min=4.05, Max=4.08, %CV=0.29); DCtrol 2 (N=12, Mean=7.36, Sd=0.03, Min=7.89, Max=7.98, %CV=0.42).
Cl mmol/L: DCtrol 1 (N=18, Mean=104, Sd=0.5, Min=103, Max=105, %CV=0.5); DCtrol 2 (N=18, Mean=118, Sd=0.8, Min=116, Max=120, %CV=0.7).
CO2 mmol/L: DCtrol 1 (N=18, Mean=14.8, Sd=0.2, Min=14.4, Max=15.1, %CV=1.4); DCtrol 2 (N=18, Mean=26.5, Sd=0.3, Min=25.7, Max=27.1, %CV=1.3).
Correlation – Serum Values on CX®:
Na: N=62, Slope=0.95, Intercept=3.59, R2=>0.99, Range=95.4 - 203.4.
K: N=91, Slope=0.99, Intercept=-0.03, R2=>0.99, Range=1.81 - 8.79.
Cl: N=76, Slope=0.97, Intercept=1.49, R2=>0.99, Range=54 - 203.
CO2: N=76, Slope=0.93, Intercept=1.58, R2=>0.99, Range=8 - 30.7.
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
NOV - 7 2003
Summary of 510(k) Submission for Mission ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems
| 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:
Sept 22, 2002
2. Identification of the Device:
| Proprietary/Trade name: | Calibrating Material, Reference Buffer |
|---|---|
| Common or usual name | Calibrators for ISE automated systems |
| Classification name: | Calibrator, secondary |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIT |
- Mission manufactures calibrators intended to serve as direct replacements to like named . products (predicate devices) manufactured by Original Equipment Manufactures (OEM)
3. Predicate Device:
- Mission claims substantial equivalence to the OEM Materials listed below: .
Substantial Equivalence Table of Product PN's & Trade Names
| Mission Product | OEM Equivalent | ||
|---|---|---|---|
| BK-443320D | CO2 Alkaline Buffer | 443320 | CO2 Alkaline Buffer |
| BK-443330D | CO2 Acid | 443330 | CO2 Acid |
| BK-450214D | ISE Electrolyte Reference | 450214 | ISE Electrolyte Reference |
- . The predicate reagents are encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively.
4. Device Description:
- The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain . desired analyte levels to provide calibration of the electrodes.
- Intended Use: ●
- . The reagents are intended for use on equivalent OEM Instruments.
510k for Mission ISE Reference & CO2 Reagents on Beckman Synchron Delta & CX® Systems
1
- . The original equipment manufacturer (OEM) of the instruments and the predicate reagents 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.
- . Performance equivalence is shown in the following manner:
- . Through a method comparison where results obtained on an equivalent OEM analyzer, calibrated with Mission calibrating material are compared with results obtained on the same analyzer calibrated with OEM calibrating material.
- . A summary of the results of these studies follows:
5. Performance Characteristics:
Precision and correlation data are collected per:
- . SOP23-01-02 Performance Study Protocol for 510(k) Submission
- Data for each instrument and each run are recorded on SOP23-03F Performance Study . Record Sheet. (See Attachment Section for Copy of Procedures)
All analytes tested passed criteria per SOP23-01-02 Performance Study Protocol for 510(k) Submission and performed equally to the OEM.
Testing was performed on CX® Delta and CX® depending on availability.
Table of Precision of Serum Controls, CSF Controls & Urine Controls on CX® Delta
| Analyte | Level | N | Mean | Sd | Min | Max | %CV |
|---|---|---|---|---|---|---|---|
| Na | |||||||
| mmol/L | DCtrol 1 | 43 | 142.0 | 6.4 | 129.6 | 157.0 | 4.5 |
| DCtrol 2 | 38 | 155.7 | 6.9 | 148.7 | 174.4 | 4.4 | |
| K | |||||||
| mmol/L | DCtrol 1 | 43 | 4.22 | 0.22 | 3.88 | 4.71 | 5.10 |
| DCtrol 2 | 45 | 8.10 | 0.37 | 7.69 | 9.21 | 4.59 | |
| Cl | |||||||
| mmol/L | DCtrol 1 | 43 | 107 | 5 | 98 | 118 | 4 |
| DCtrol 2 | 38 | 118 | 5 | 113 | 131 | 4 | |
| Ca | |||||||
| mmol/L | DCtrol 1 | 31 | 2.51 | 0.08 | 2.39 | 2.69 | 3.06 |
| DCtrol 2 | 27 | 3.35 | 0.18 | 3.16 | 4.00 | 5.23 | |
| CO2 | |||||||
| mmol/L | DCtrol 1 | 40 | 14.8 | 0.7 | 13.1 | 16.0 | 4.4 |
| DCtrol 2 | 43 | 25.4 | 1.1 | 23.1 | 28.2 | 4.2 | |
| Na | |||||||
| mmol/L | CSF 1 | 13 | 127.4 | 6 | 119.4 | 139.0 | 3.8 |
| CSF 2 | 12 | 159.9 | 5 | 153.8 | 170.3 | 4.9 | |
| Cl | |||||||
| mmol/L | CSF 1 | 13 | 89 | 4 | 84 | 95 | 4 |
| CSF 2 | 12 | 105 | 3 | 102 | 111 | 3 | |
| Na | |||||||
| mmol/L | URINE 1 | 48 | 65.6 | 4.9 | 59.7 | 77.0 | 7.5 |
| URINE 2 | 44 | 208.2 | 7.9 | 197.1 | 227.8 | 3.8 | |
| K | |||||||
| mmol/L | URINE 1 | 48 | 33.7 | 2.2 | 31.5 | 39.0 | 6.4 |
| URINE 2 | 45 | 108.4 | 6.1 | 101.4 | 122.9 | 5.6 | |
| Cl | |||||||
| mmol/L | URINE 1 | 47 | 100 | 6 | 92 | 113 | 6 |
| URINE 2 | 47 | 256 | 10 | 245 | 280 | 4 | |
| Ca | |||||||
| mmol/L | URINE 1 | 29 | 1.57 | 0.14 | 1.44 | 1.90 | 8.97 |
| URINE 2 | 32 | 3.50 | 0.14 | 3.27 | 3.84 | 3.99 |
2
| Analyte | Level | N | Mean | Sd | Min | Max | %CV |
|---|---|---|---|---|---|---|---|
| Ca mmol/L | Normal | 18 | 2.42 | 0.06 | 2.30 | 2.52 | 2.5 |
| Lo | 18 | 1.96 | 0.06 | 1.86 | 2.05 | 3.1 | |
| High | 18 | 3.65 | 0.13 | 3.47 | 3.84 | 3.6 |
Table of Precision of Serum Samples on CX® Delta
Table of Precision of Serum Controls on CX®
| Analyte | Level | N | Mean | Sd | Min | Max | %CV |
|---|---|---|---|---|---|---|---|
| Na mmol/L | DCtrol 1 | 18 | 139.7 | 0.08 | 138.5 | 141.1 | 0.6 |
| Na mmol/L | DCtrol 2 | 18 | 154.1 | 1.03 | 152.6 | 156.0 | 0.7 |
| K mmol/L | DCtrol 1 | 14 | 4.07 | 0.01 | 4.05 | 4.08 | 0.29 |
| K mmol/L | DCtrol 2 | 12 | 7.36 | 0.03 | 7.89 | 7.98 | 0.42 |
| Cl mmol/L | DCtrol 1 | 18 | 104 | 0.5 | 103 | 105 | 0.5 |
| Cl mmol/L | DCtrol 2 | 18 | 118 | 0.8 | 116 | 120 | 0.7 |
| CO2 mmol/L | DCtrol 1 | 18 | 14.8 | 0.2 | 14.4 | 15.1 | 1.4 |
| CO2 mmol/L | DCtrol 2 | 18 | 26.5 | 0.3 | 25.7 | 27.1 | 1.3 |
Table of Correlation – Serum Values on CX®
| Analyte | N | Slope | Intercept | R2 | Range |
|---|---|---|---|---|---|
| Na | 62 | 0.95 | 3.59 | >0.99 | 95.4 - 203.4 |
| K | 91 | 0.99 | -0.03 | >0.99 | 1.81 - 8.79 |
| Cl | 76 | 0.97 | 1.49 | >0.99 | 54 - 203 |
| CO2 | 76 | 0.93 | 1.58 | >0.99 | 8 - 30.7 |
3
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" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, creating a sense of depth and movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 7 2003
Diamond Diagnostics, Inc. c/o Ms. Linda M. Stundtner QA/RA Manager Mission Diagnostics 331 Fiske Street Holliston, MA 01746
Re: K033061
Trade/Device Name: Mission Diagnostic ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX 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).
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,
Steven Butman
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
5
510(k) Number K033041
Device Name:
Mission Diagnostic ISE Reference & CO2 Reagents for Beckman Synchron Delta & CX® Systems
Indication For Use:
- The three products encompassed by this request are intended for in-vitro diagnostics use. ●
| Mission Product | |
|---|---|
| BK-443320D | CO2 Alkaline Buffer |
| BK-443330D | CO2 Acid |
| BK-450214D | ISE Electrolyte Reference |
- Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and . TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2.
- The CO2 Acid reagent is used to release CO2 from samples .
- The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. .
- Mission reagents are intended to serve as direct replacements to the predicate devices 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)
Carol Benson for Jean Cooper, OVM
Division Sign-Off
o Diagnostic De ation and 22
510(k) K033061
(Optional format 3-10-98)