(260 days)
Not Found
No
The device description and intended use clearly define the product as calibrators (liquid solutions) for laboratory instruments, with no mention of software, algorithms, or any technology that would incorporate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as a calibrator solution for laboratory instruments that measure electrolytes, and its intended use is to provide calibration points. It does not perform any therapeutic function on a patient.
No
The device is a calibrator, used to provide calibration points for electrodes on diagnostic instruments, rather than performing diagnostics itself.
No
The device description clearly states it is a liquid solution packaged in vials, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are "intended to provide calibration points for the Na+, K+, Cl-, and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments." These instruments are used to measure analytes (Na+, K+, Cl-, and CO2) in biological samples (implied by the nature of the analytes and the typical use of such instruments in clinical settings).
- Device Description: The description details the composition of the calibrators as "aqueous buffered solution of electrolytes and preservative in De-ionized water." These are reagents used in the process of performing diagnostic tests.
- Predicate Device: The predicate device listed (K945271; ATAC 8000 ISE Calibrators) is also an IVD, which further supports the classification of this device.
Calibrators are essential components of many in vitro diagnostic tests. They are used to ensure the accuracy and reliability of the measurements obtained from the diagnostic instrument. Therefore, based on the intended use and the nature of the device, it clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators are intended to provide calibration points for the Na+, K+, Cl-, and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments.
Product codes
JIT
Device Description
Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are intended to serve as a direct replacement to ATAC 8000/Envoy 500 ISE Calibrators. Diamond Calibrator Low consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution. Diamond Calibrator High consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution. Each calibrator is comprised of the following concentrations of analytes,
PN
BT-6620943D Low
BT-6620944D High
ISE Calibrator Na+ mmol/L
3.05 ± 0.05
10.2 ± 0.1
K+ mmol/L 78 ± 2 126 ± 1
Cl- mmol/L 92 ± 2.0 162 ± 1.0
CO2 mmol/L 11 ± 1 34.5 ± 1
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)
Stability: Accelerated (high temperature) stress test was conducted to support stability claim. Heat stressed reagents showed that calibrator parameters remained within specification thereby demonstrating stability equivalent to ATAC 8000 calibrators. Traceability: All testing for analytes were conducted using Standards prepared from NIST salts. Testing was also conducted using reference methods.
Analyte: Na, K, Standard Used for Determination of Analyte Value: NIST 919a, 918a, Instrument Used: IL 943 (Flame Photometry)
Analyte: Cl, Standard Used for Determination of Analyte Value: NIST 919a, Instrument Used: Corning 925, SAT-500 Salt Analyzer, (Titrimetric)
Analyte: CO2, Standard Used for Determination of Analyte Value: NIST 351, Instrument Used: Hitachi 912, Olympus-Beckman CX-7
Expected Values (Controls, Calibrators, or Methods): Target values, (or specifications) were obtained by testing reagents analytically prior to bottling, adjusting if necessary to meet specifications, testing analytically during the bottling process and prior to release to stock for distribution.
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
§ 862.1150 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
5. 510(k) Summary
121027
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
| Applicant: | Diamond Diagnostics Inc
333 Fiske Street
Holliston MA 01746 | | | | | DEC 2 0 2012 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------|---------------|---------------|--------------|
| Contact Person: | Kathy Cruz
Quality Assurance Manager
Phone: (508) 429-0450 ext. 358
Fax: (508) 429-0452 | | | | | |
| Date Prepared: | 10/25/2012 | | | | | |
| Classification Name: | Calibrator, secondary | | | | | |
| Trade Name: | Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators | | | | | |
| Device Classification: | 21 CFR 862.1150 | | | | | |
| Device Class: | Class II | | | | | |
| Classification Panel: | Clinical Chemistry | | | | | |
| Product Code: | JIT | | | | | |
| Intended Use: | Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators
are intended to provide calibration points for the Na+, K+, Cl-, and CO2
electrodes on the ATAC 8000 and Envoy 500 instruments. | | | | | |
| Description of Device: | Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are
intended to serve as a direct replacement to ATAC 8000/Envoy 500
ISE Calibrators. | | | | | |
| | Diamond Calibrator Low consists of an aqueous buffered solution of
electrolytes and preservative in De-ionized water. It contains NO
human or animal products. It is a liquid packaged in a 22ml screw top
amber vial. Each vial contains 20 ml of solution. | | | | | |
| | Diamond Calibrator High consists of an aqueous buffered solution of
electrolytes and preservative in De-ionized water. It contains NO
human or animal products. It is a liquid packaged in a 22ml screw top
amber vial. Each vial contains 20 ml of solution. | | | | | |
| | Each calibrator is comprised of the following concentrations of
analytes, | | | | | |
| PN | ISE
Calibrator | Na+
mmol/L | K+
mmol/L | Cl-
mmol/L | CO2
mmol/L | |
BT-6620943D
BT-6620944D
Low
High
12/18/2012
3.05 ± 0.05
10.2 ± 0.1
78 ± 2
126 ± 1
92 ± 2.0
162 ± 1.0
11 ± 1
34.5 ± 1
1
Predicate Device:
Predicate 510(k) number(s): K945271
Comparison with predicate:
| Characteristics | Diamond ATAC 8000/Envoy 500 ISE
Calibrators | ATAC 8000 ISE
Calibrators |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Device | New | Predicate |
| 510(k) Number | K121027 | K945271 |
| PN | BT-6620943D ISE Low Calibrator
BT-6620944D ISE High Calibrator
BT-6620940D (Kit) | 347240 ISE Low
Calibrator
347240 ISE High
Calibrator
347-240 (Kit) |
| Product Type | Calibrators | same |
| Intended Use | For in-vitro diagnostics use to provide
calibration points for the Na+, K+, Cl-
and CO2 electrodes on the ATAC 8000
instrument having an ISE Module | same |
| Matrix | Aqueous buffered solution of salts &
preservatives in De-ionized water.
Contains NO human or animal
materials. | same |
| Packaging, Vial | Glass Vial | Same |
| Packaging, Product | Box Level, 2x20mL | 2x6x20mL |
| Storage | 18-25°C | same |
| Shelf Life for BT-
6620943D | 24 months | same |
| Shelf Life for BT-
620944D | 24 months | same |
Stability:
Accelerated (high temperature) stress test was conducted to support stability claim. Heat stressed reagents showed that calibrator parameters remained within specification thereby demonstrating stability equivalent to ATAC 8000 calibrators.
Traceability:
All testing for analytes were conducted using Standards prepared from NIST salts. Testing was also conducted using reference methods.
| Analyte | Standard Used for Determination of
Analyte Value | Instrument Used |
|---------|-----------------------------------------------------|------------------------------------------------------|
| Na, K | NIST 919a, 918a | IL 943 (Flame Photometry) |
| Cl | NIST 919a | Corning 925, SAT-500 Salt
Analyzer, (Titrimetric) |
| CO2 | NIST 351 | Hitachi 912, Olympus-Beckman
CX-7 |
Expected Values (Controls, Calibrators, or Methods),
Target values, (or specifications) were obtained by testing reagents analytically prior to bottling, adjusting if necessary to meet specifications, testing analytically during the bottling process and prior to release to stock for distribution.
Conclusion:
Based on the results submitted in this pre market notification Diamond ATAC 8000 ISE Calibrators are substantially equivalent to the ATAC 8000 ISE Calibrators in Composition, Intended use, Packaging, and Storage for the measurement of Na *, K , CI , and CO2.
2
2
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 features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines intersecting a horizontal bar. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 20, 2012
Diamond Diagnostics, Inc. c/o Kathy Cruz 333 Fiske Street Holliston, MA 01746
Re: K121027
Trade/Device Name: ATAC 8000/Envoy 500 ISE Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator . Regulatory Class: II Product Code: JIT Dated: October 25, 2012 Received: October 26, 2012
Dear Ms. Cruz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2-Ms. Cruz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carol C. Benson for
Courtney H. Lias Director. Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121027
Device Name: Diamond Diagnostics ATAC 8000/ Envoy 500 ISE calibrators
Indications for Use:
Diamond Diagnostics Calibrators for ATAC 8000 and Envoy 500 instruments are intended to provide calibration points for the Nat, K+, Cli and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Louise Romankeyles
sion Sign-( Office of In Vitro Diagnostics and Radiological Health
510(k) K121027