CALIBRATING MATERIAL, BUFFERS, STANDARD
Device Facts
| Record ID | K022027 |
|---|---|
| Device Name | CALIBRATING MATERIAL, BUFFERS, STANDARD |
| Applicant | Mission Diagnostics |
| Product Code | JIT · Clinical Chemistry |
| Decision Date | Jul 22, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Intended 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.
Device Story
Aqueous reagent solutions containing salts; used as direct replacements for OEM-manufactured calibrators; function to calibrate electrodes and rinse sample flow paths in automated pH/blood gas and electrolyte analyzers; used in clinical laboratory settings; handled by laboratory personnel; no sodium azide added; ensures continued operation and accuracy of OEM diagnostic instrumentation.
Clinical Evidence
Bench testing only. Precision and correlation data were collected according to internal performance study protocols (SOP23-01-02) and recorded on standardized data sheets to verify performance against OEM predicate reagents.
Technological Characteristics
Aqueous reagent solutions containing salts; formulated for specific analyte levels to calibrate electrodes and rinse sample paths; no sodium azide; designed as direct replacements for OEM-specific calibrators; compatible with existing OEM pH/blood gas and electrolyte analyzer hardware.
Indications for Use
Indicated for in-vitro diagnostic use to calibrate electrodes and flush sample flow paths in equivalent OEM pH/blood gas and electrolyte analyzers.
Regulatory Classification
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.)
Special Controls
*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.
Predicate Devices
- Dade Dimension ISE Standard C D100
- Dade Dimension ISE Standard A D102
- Dade Dimension ISE Standard B D103A
- Dade Dimension ISE Standard C D200
- Dade Dimension ISE Standard A D202
- Dade MultiPLY IMT Standard A S540
- Dade MultiPLY IMT Standard B S550
- Dade MultiPLY IMT Standard C S560
- Roche Standard 1 for Cobas ISE Module 46997
- Roche Standard 2 for Cobas ISE Module 46998
- S1556 Code No. 943-118 Red Calibrating Solution (High pH)
- S1546 Code No. 943-117 Green Calibrating Solution (Low pH)
- S1565 Code No. 943-791 Calibrating Solution 1, Red 3
- S1575 Code No. 943-792 Calibrating Solution 2, Red 4
- S1585 Code No. 943-831 Calibrating Solution 1, Blue 3
- S1595 Code No. 943-832 Calibrating Solution 2, Blue 4
- S1545 Code No. 943-837 Calibrating Solution 1, red
- S1555 Code No. 943-839 Calibrating Solution 2, green
- S1580 Code No. 943-959 Calibrating Solution 1, Red 9
- S1590 Code No. 943-960 Calibrating Solution 2, Red 10
- 33360 IL Test 7.384 pH Reference Buffer
- 31060 IL Test 6.840 pH Reference Buffer
- 09831800 IL Test Cal 1
- 09831900 IL Test Cal 2
Related Devices
- K033060 — CALIBRATING MATERIAL, CALIBRATING STANDARDS · Diamond Diagnostics, Inc. · Mar 4, 2004
- K020894 — CALIBRATING MATERIAL, CAL-PAK, BUFFERS · Mission Diagnostics · Apr 29, 2002
- K020596 — CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS · Diamond Diagnostics, Inc. · Mar 23, 2002
- K981795 — CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO · Thermo Bioanalysis Corp. · Jun 12, 1998
Submission Summary (Full Text)
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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 _
K022027
#### 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
