(135 days)
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No
The summary describes a standard enzymatic assay kit for measuring carbon dioxide, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic (IVD) assay kit used for the quantitative determination of carbon dioxide, which aids in diagnosis rather than providing direct therapy.
Yes
The device is described as an "Enzymatic Assay Kit" intended for the "quantitative determination of carbon dioxide (CO2) in serum and plasma," which are activities performed to diagnose or monitor medical conditions. Its use with calibrators and controls further supports its diagnostic purpose.
No
The device is described as an "Assay Kit" and "Calibrator," which are physical components used for chemical analysis. The summary does not mention any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of carbon dioxide (CO2) in serum and plasma." Serum and plasma are biological samples taken in vitro (outside the body).
- Method: It's an "Enzymatic Assay Kit," which is a common method used in laboratory testing of biological samples.
- Components: It includes a "Calibrator" and "Control Set," which are standard components of IVD kits used for accurate and reliable testing.
- Predicate Device: The predicate device listed (K990754; CARBON DIOXIDE-L3K ASSAY) is also an IVD for carbon dioxide testing.
All these factors strongly indicate that this device is designed to be used in vitro for diagnostic purposes.
N/A
Intended Use / Indications for Use
Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples. Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.
Product codes (comma separated list FDA assigned to the subject device)
KHS, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
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(JUL 2 1 2006
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is K060619.
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 3550 General Atomics Court |
| San Diego, CA 92121 | |
| Phone: | 858-455-4761 |
| Fax: | 858-455-4750 |
| Name of Contact Person: | Roland Strickland |
| Diazyme Laboratories | |
| 3550 General Atomics Court | |
| San Diego, CA 92121 | |
| Phone: 858-455-4761 | |
| Fax: 858-455-4750 | |
| Date the summary was prepared: | February 23, 2006 |
| Name of the device: | In Vitro Bicarbonate/Carbon Dioxide Test System |
| Trade Name: | Diazyme Carbon Dioxide Enzymatic Assay |
| Common/Usual Name: | Bicarbonate/Carbon Dioxide Test System |
| Classification Name: | Enzymatic, Carbon-Dioxide |
| Device Class | II |
| Predicate Device: | The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: CARBON DIOXIDE-L3K ASSAY (K990754) manufactured by Diagnostic Chemicals Limited, Oxford, CT, USA. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. Encircling the eagle is text, which appears to be the name of an organization or agency. The text is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Roland Strickland Quality Assurance Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121
JUL 2 1 2006
K060619 Re:
Trade/Device Name: Diazyme Carbon Dioxide Enzymatic Assay Kit Diazyme Carbon Dioxide Control Set Regulation Number: 21 CFR8862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS, JJX Dated: June 30, 2006 Received: July 7, 2006
Dear Mr. Strickland:
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).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto G.
Alberto Gutierrez, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K060619 Device Name: Diazyme Carbon Dioxide Enzymatic Assay Kit Diazyme Carbon Dioxide Control Set Indications For Use: Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples. Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.
Prescription Use X (Part 21 CFR 801 Subpart D)
રૂકા
AND/OR
Over-The-Counter Use (21 CFR 801 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) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | Page 1 of 1 |
| DIAZYME LABORATORIES DIVISION, GENERAL ATOMICS | |
| 150 GENERAL ATOMICS COURT, SAN DIEGO, CA 92121-1194 | |
| PO BOX 85608, SAN DIEGO, CA 92186 5608 | |
| (858) 455-3000 | Page 14 |