(31 days)
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent OEM Analyzers.
The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path. Mission uses a similar composition, description and packaging as that used by the OEM in its products.
This document pertains to the 510(k) submission for Mission Diagnostic Reagents. It's important to note that this submission is for calibrating reagents used with pH/Blood Gas and Electrolyte Analyzers, not for a medical device that diagnoses or treats patients. Therefore, the typical acceptance criteria and study designs for diagnostic AI/ML models (e.g., sensitivity, specificity, reader studies, ground truth involving expert consensus or pathology) are not directly applicable here.
Instead, the "acceptance criteria" for these calibrating reagents largely revolve around demonstrating substantial equivalence to existing predicate devices (the OEM calibrators) in terms of composition and performance when used with the specified instruments. The "study" mentioned is a performance study to show this equivalence.
Here's an attempt to answer the questions based on the provided text, adapting for the nature of the device:
Acceptance Criteria and Device Performance Study for Mission Diagnostic Calibrating Reagents
The "acceptance criteria" for these calibrating reagents are implicitly tied to demonstrating substantial equivalence to the predicate OEM calibrators, specifically in terms of their ability to correctly calibrate the target instruments. The primary performance characteristic assessed is correlation and precision compared to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the device performance is evaluated through "Precision and correlation data collected per SOP23-01-02 Performance Study Protocol for 510(k) Submission 0". The reported performance is implicitly that the Mission Diagnostics reagents are substantially equivalent to the OEM equivalents, indicating that the precision and correlation achieved are acceptable for their intended use as direct replacements.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Precision | Demonstrated precision comparable to OEM predicate calibrators. | Data collected per SOP23-01-02 and recorded on SOP23-03F. |
| Correlation | Demonstrated correlation comparable to OEM predicate calibrators. | Data collected per SOP23-01-02 and recorded on SOP23-03F. |
| Functional Equivalence | Able to calibrate electrodes and flush sample path on OEM instruments as intended by the OEM predicate. | The FDA’s substantial equivalence determination confirms this. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It states that "Data for each instrument and each run are recorded on SOP23-03F Performance Study O Record Sheet." This suggests that multiple runs were performed on each instrument with the Mission Diagnostic calibrators.
- Data Provenance: The data appears to be prospective as it was collected specifically for this 510(k) submission as part of a "Performance Study Protocol." The country of origin of the data is not explicitly stated, but given the submitter's address is in Holliston, MA, USA, and the FDA is the reviewing body, it is highly probable the testing was conducted in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section does not apply in the traditional sense of diagnostic AI/ML devices. For calibrating reagents, the "ground truth" is typically established by the known stable values of the calibrators themselves, which are manufactured to highly precise specifications. The accuracy would be assessed against these known values and the performance of the predicate calibrators. There are no "experts" establishing a ground truth in the context of clinical interpretation, but rather skilled laboratory personnel following a quality-controlled protocol.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require adjudication. The performance is objectively measured by the instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic device that involves human readers or interpretation of clinical cases. Therefore, an MRMC study and measures like "human readers improve with AI vs without AI assistance" are not relevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the device itself (calibrating reagent) is "standalone" in that it performs its function without human interpretation, the concept of "standalone performance" in the context of AI/ML algorithms is not applicable here. The calibrator's performance is intrinsically linked to its interaction with the analyzer instrument. The performance study measures the calibrator's output on the instrument.
7. The Type of Ground Truth Used
The ground truth for calibrating reagents is the known, manufactured analyte concentrations/pH values of the calibrating solutions themselves. These values are established through rigorous manufacturing processes and quality control, traceable to reference standards. The performance study evaluates if the instrument, when calibrated with the Mission Diagnostics reagents, accurately measures these known values and performs comparably to when calibrated with the OEM predicate.
8. The Sample Size for the Training Set
Not applicable. These are chemical reagents, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set.
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K022027
Page 48 of 60
JUL 2 2 2002
Abbreviated 510(k) Submission for Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers
Submitter's Name & Address 1.
Mission Diagnostics 331 Fiske St Holliston MA 01746 FAX: 508-429-0452
Contact Person: Linda M Stundtner QA/RA Manager 508-429-0450
Establishment Registration Number: 300-36-56-721
Date of Preparation:
June 19, 2002
2. Identification of the Device:
| Proprietary/Trade name: | Calibrating Material, Buffers, Standards |
|---|---|
| Common or usual name: | Calibrators for ISE and/or pH/Blood Gas 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 manufactured by Original Equipment Manufactures (OEM)
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3. Predicate Device:
| Mission Product | OEM Equivalent | |
|---|---|---|
| DA-D100D | ISE Standard C | Dade Dimension® ISE Standard C D100 |
| DA-D102D | ISE Standard A | Dade Dimension® ISE Standard A D102 |
| DA-D103AD | ISE Standard B | Dade Dimension® ISE Standard B D103A |
| DA-D200D | ISE Standard C | Dade Dimension® ISE Standard C D200 |
| DA-D202D | ISE Standard A | Dade Dimension® ISE Standard A D202 |
| DA-S540D | IMT Standard A | Dade MultiPLY® IMT Standard A S540 |
| DA-S550D | IMT Standard B | Dade MultiPLY® IMT Standard B S550 |
| DA-S560D | IMT Standard C | Dade MultiPLY® IMT Standard C S560 |
| RO-46997D | ISE Standard 1 | Roche Standard 1 for Cobas® ISE Module 46997 |
| RO-46998D | ISE Standard 2 | Roche Standard 2 for Cobas® ISE Module 46998 |
| RD-943118D | Red Cal S1556 | S1556 Code No. 943-118 Red Calibrating Solution (High pH) |
| RD-943117D | Green Cal S1546 | S1546 Code No. 943-117 Green Calibrating Solution (Low pH) |
| RD-943791D | Cal. Sol. 7.4; 3 S1565 | S1565 Code No. 943-791 Calibrating Solution 1, Red 3 |
| RD-943792D | Cal. Sol. 6.8; 4 S1575 | S1575 Code No. 943-792 Calibrating Solution 2, Red 4 |
| RD-943831D | Cal. Sol. 1; 3 S1585 | S1585 Code No. 943-831 Calibrating Solution 1, Blue 3 |
| RD-943832D | Cal. Sol. 2; 4 S1595 | S1595 Code No. 943-832 Calibrating Solution 2, Blue 4 |
| RD-943837D | Cal 1; S1545 | S1545 Code No. 943-837 Calibrating Solution 1, red |
| RD-943839D | Cal 2; S1555 | S1555 Code No. 943-839 Calibrating Solution 2, green |
| RD-943959D | Cal 1; 9 S1580 | S1580 Code No. 943-959 Calibrating Solution 1, Red 9 |
| RD-943960D | Cal 2; 10 S1590 | S1590 Code No. 943-960 Calibrating Solution 2, Red 10 |
| IL-03336004D | 7.384 pH Buffer | 33360 IL Test™ 7.384 pH Reference Buffer |
| IL-03106004D | 6.840 pH Buffer | 31060 IL Test™ 6.840 pH Reference Buffer |
| IL-09831804D | Cal 1 | 09831800 IL Test™ Cal 1 |
| IL-09831904D | Cal 2 | 09831900 IL Test™ Cal 2 |
Substantial Equivalence Table of Product PN's & Trade Names
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 and rinse the sample path.
- Intended Use:
- . The reagents are intended for use on equivalent OEM Instruments.
- . The OEM is the original equipment manufacturer 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 0
- Data for each instrument and each run are recorded on SOP23-03F Performance Study O Record Sheet. (See Attachment Section for Copy of Procedure and Data Record Sheet)
510(k) Submission for Mission Diagnostics Reagents on pH/BG &/or Electrolyte Analyzers
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 symbol resembling an abstract eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
'JUL 2 2 2002
Ms. Linda Stundtner OA/RA Manager Diamond Diagnostics Inc. Mission Diagnostics 333 Fiske Street Holliston, MA 01746
Re: K022027
Trade/Device Name: Mission Diagnostic Calibrating Reagents for pH/BG &/or Electrolyte Analyzers
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 19, 2002 Received: June 21, 2002
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 vour 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k( Number _
Device Name: Mission Diagnostic Calibrating Reagents for pH/BG &/or 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 and flushing the sample flow path of the equivalent OEM Analyzers.
Substantial Equivalence Table of Product PN's & Trade Names
| Mission Product | OEM Equivalent | |
|---|---|---|
| DA-D100D | ISE Standard C | Dade Dimension® ISE Standard C D100 |
| DA-D102D | ISE Standard A | Dade Dimension® ISE Standard A D102 |
| DA-D103AD | ISE Standard B | Dade Dimension® ISE Standard B D103A |
| DA-D200D | ISE Standard C | Dade Dimension® ISE Standard C D200 |
| DA-D202D | ISE Standard A | Dade Dimension® ISE Standard A D202 |
| DA-S540D | IMT Standard A | Dade MultiPLY® IMT Standard A S540 |
| DA-S550D | IMT Standard B | Dade MultiPLY® IMT Standard B S550 |
| DA-S560D | IMT Standard C | Dade MultiPLY® IMT Standard C S560 |
| RO-46997D | ISE Standard 1 | Roche Standard 1 for Cobas® ISE Module 46997 |
| RO-46998D | ISE Standard 2 | Roche Standard 2 for Cobas® ISE Module 46998 |
| RD-943118D | Red Cal S1556 | S1556 Code No. 943-118 Red Calibrating Solution (High pH) |
| RD-943117D | Green Cal S1546 | S1546 Code No. 943-117 Green Calibrating Solution (Low pH) |
| RD-943791D | Cal. Sol. 7.4; 3 S1565 | S1565 Code No. 943-791 Calibrating Solution 1, Red 3 |
| RD-943792D | Cal. Sol. 6.8; 4 S1575 | S1575 Code No. 943-792 Calibrating Solution 2, Red 4 |
| RD-943831D | Cal. Sol. 1; 3 S1585 | S1585 Code No. 943-831 Calibrating Solution 1, Blue 3 |
| RD-943832D | Cal. Sol. 2; 4 S1595 | S1595 Code No. 943-832 Calibrating Solution 2, Blue 4 |
| RD-943837D | Cal 1; S1545 | S1545 Code No. 943-837 Calibrating Solution 1, red |
| RD-943839D | Cal 2; S1555 | S1555 Code No. 943-839 Calibrating Solution 2, green |
| RD-943959D | Cal 1; 9 S1580 | S1580 Code No. 943-959 Calibrating Solution 1, Red 9 |
| RD-943960D | Cal 2; 10 S1590 | S1590 Code No. 943-960 Calibrating Solution 2, Red 10 |
| IL-03336004D | 7.384 pH Buffer | 33360 IL Test™ 7.384 pH Reference Buffer |
| IL-03106004D | 6.840 pH Buffer | 31060 IL Test™ 6.840 pH Reference Buffer |
| IL-09831804D | Cal 1 | 09831800 IL Test™ Cal 1 |
| IL-09831904D | Cal 2 | 09831900 IL Test™ Cal 2 |
. 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.
- . Sodium Azide is NOT added to any of the formulations
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of the Device Evaluation (ODE)
| Ruth Chelton for Jean Cooper | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K022027 |
(Optional format 3-10-98)
510(k) Submission for Mission Diagnostics Reagents on pH/BG &/or Electrolyte Analyzers
§ 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.