(70 days)
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No
The description focuses on combining existing tests into a new panel and the device's mechanical and chemical analysis process, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) test used for quantitative measurement of various substances in blood to assess health conditions, not to treat them.
Yes
Explanation: The device measures various chemical levels in blood (sodium, potassium, glucose, etc.) to assess conditions like kidney function, hydration, and blood sugar, which are all diagnostic activities.
No
The device is a physical cartridge containing reagents and designed to interact with a hardware analyzer, making it a hardware medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the cartridge is used for the "quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood." These are measurements performed on biological samples (blood) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of various conditions.
- Device Description: The description details how the device analyzes blood samples in vitro using a cartridge and analyzer system.
- Predicate Devices: The listed predicate devices (K053110 i-STAT CG8+ Cartridge; i-STAT EC9+ Cartridge; i-STAT CREA Cartridges) are also IVD devices, indicating that the i-STAT CHEM8+ Cartridge falls within the same regulatory category.
The core function of the device is to perform tests on biological samples in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The i-STAT CHEM8+ Cartridge is intended to be used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood.
The i-STAT CHEM8+ Cartridge is useful for monitoring a variety of conditions. The i-STAT CHEM8+ Cartridge is used as a screening and diagnostic tool in the inpatient and outpatient setting for a variety of conditions, including assessment of the critically ill, rapid assessment of electrolyte and fluid balance, and assessment of kidney function. The panel of tests is used in the neonatal setting for every aspect of patient care where lab analysis is important, including assessment of electrolyte and fluid balance and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, JFP, CGA, CGL, JFL, CDS, JPI
Device Description
The modified device is the i-STAT CHEM8+ Cartridge. The modifications comprise a combination of several tests, all of which are on the market and reside in other i-STAT cartridges, into a new panel of tests. As is shown in Table 2, the new i-STAT CHEM8+ Cartridge contains a panel comprised of nine reported tests and two calculated tests as is indicated on the labeling for this device. Of these nine reported test, eight tests (glucose, ionized calcium, sodium, potassium, chloride, carbon dioxide, urea nitrogen and creatinine) are commonly referred to as a "basic metabolic panel". The two tests to be reported as calculated parameters are anion gap and hemoglobin. The i-STAT CHEM8+ Cartridge is a single-use device that is to be used with the i-STAT 1 Analyzer. As with other i-STAT Cartridges, two or three drops of venous, arterial or capillary blood is dispensed into the cartridge, the blood are sealed inside the cartridge with the snap closure, and the cartridge is then inserted into the analyzer. The analysis cycle is automatic and is controlled by software in the analyzer. Cartridges are calibrated at the factory. This cartridge is similar in design to the other i-STAT cartridges that are used for the same or similar in vitro diagnostic tests. The i-STAT CHEM8+ Cartridge is manufactured using the same process technology and equipment that is used for existing i-STAT cartridges.
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
The panel of tests is used in the neonatal setting for every aspect of patient care where lab analysis is important, including assessment of electrolyte and fluid balance and blood sugar level.
Intended User / Care Setting
Used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood. The i-STAT CHEM8+ Cartridge is used as a screening and diagnostic tool in the inpatient and outpatient setting for a variety of conditions.
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)
The performance of the tests contained in the modified (i-STAT CHEM8+) device and in the existing devices are equivalent for all diagnostic purposes.
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.
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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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§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
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ad V. J Mediany
Image /page/0/Picture/2 description: The image shows the logo for i-STAT Corporation. The logo is in black and white and features the company name in a bold, sans-serif font. The "i" in i-STAT is lowercase, while the rest of the letters are uppercase. The word "CORPORATION" is written in smaller letters below the company name.
510(k) Summary
Applicant
i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Phone (609) 443-9300 Fax (609) 443-9310
Contact person
Paul VanDerWerf, Ph.D. Director Requlatory Affairs
Date summary prepared
07 October 2005
Summary
Trade Name: i-STAT CHEM8+ Cartridge
Common Name: metabolic panel
This Special 510(k) demonstrates that the modified device (i-STAT CHEM8+ Cartridge), comprising tests for sodium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit is equivalent to those same tests that are present in the existing i-STAT CG8+, i-STAT EC9+, and i-STAT CREA Cartridges. The i-STAT CHEM8+ Cartridge is intended to be used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood. The modified device was developed following the requirements for design controls in 21 CFR 820.3. Hazards were identified and the associated risk was evaluated; all unacceptable risks were controlled to an acceptable level by design features and/or labeling. Users needs in the form of design inputs were defined and served as the basis for a design validation. The i-STAT CHEM8+ Cartridge is compatible with the i-STAT Model 300 (i-STAT1) Analyzer.
A comparison of the modified device with the existing un-modified devices shows that the modified device is substantially equivalent in safety and effectiveness. The modified device is not altered with respect to intended use or the technology employed. A table that compares the existing, unmodified devices and the modified device is included.
(0) Windsor Ceiter Drive, Iras Windsor, NJ 08520 • Tel: (69-443-9300 • Tas: 6(9-443-9310 • Web: http://www.i-STAT.com™
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DESCRIPTION OF THE MODIFIED DEVICE
The modified device is the i-STAT CHEM8+ Cartridge. The modifications comprise a combination of several tests, all of which are on the market and reside in other i-STAT cartridges, into a new panel of tests. The modified device and the cleared devices, together with the tests that are in each cartridge type, are shown in Table 2. The tests that are indicated by an "X" in Table 2 are to be incorporated into the modified device. The tests indicated by a "y" are reported in the existing devices but will not be reported in the modified device.
| | CLEARED DEVICES | | | MODIFIED
DEVICE |
|-----------------|-----------------|-------------|-------------|--------------------|
| TEST/ANALYTE | i-STAT Crea | i-STAT CG8+ | i-STAT EC8+ | i-STAT
CHEM8+ |
| Creatinine | X | | | X |
| Ionized Calcium | | X | | X |
| Sodium | | X | X | X |
| Potassium | | X | X | X |
| Chloride | | | X | X |
| Urea Nitrogen | | | X | X |
| Glucose | | X | X | X |
| Hematocrit | | X | X | X |
| PCO2 | | y | y | |
| pH | | y | y | |
| Total CO2 | | X | X | X |
| Anion Gap | | | X | X |
| Hemoglobin | | X | X | X |
| Base Excess | | y | y | |
| HCO3 | | y | y | |
| PO2 | | y | | |
| sO2 | | y | | |
Table 2. Comparison of the Existing, Legally-Marketed, i-STAT Devices with the Modified Device.
As is shown in Table 2, the new i-STAT CHEM8+ Cartridge contains a panel comprised of nine reported tests and two calculated tests as is indicated on the labeling for this device. Of these nine reported test, eight tests (glucose, ionized calcium, sodium, potassium, chloride, carbon dioxide, urea nitrogen and creatinine) are commonly referred to as a "basic metabolic panel". The two tests to be reported as calculated parameters are anion gap and hemoglobin.
The performance of the tests contained in the modified (i-STAT CHEM8+) device and in the existing devices are equivalent for all diagnostic purposes. The i-STAT CHEM8+ Cartridge is a single-use device that is to be used with the i-STAT 1 Analyzer. As with other i-STAT Cartridges, two or three drops of venous, arterial or capillary blood is dispensed into the cartridge, the blood are sealed inside the cartridge with the snap closure, and the cartridge is then inserted into the analyzer. The analysis cycle is automatic and is controlled by software in the analyzer. Cartridges are calibrated at the factory. This cartridge is similar in design to the other i-STAT cartridges that are used for the same or similar in vitro diagnostic tests. The i-STAT CHEM8+ Cartridge is manufactured using the same process technology and equipment that is used for existing i-STAT cartridges.
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DEPARTMENT OF HEAL TH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN I 3 2006
Paul VanDerWerf, Ph.D. Director Regulatory Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520
Re: K053110
Trade/Device Name: i-STAT CHEM8+ Cartridge Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JFP, CGA, CGL, JFL, CDS, JPI Dated: December 16, 2005 Received: December 19, 2005
Dear Dr. VanDerWerf:
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) I mis letter will and w you to FDA finding of substantial equivalence of your device to a legally premarket notification " "I selection 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, rr you coons 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 I ou may 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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2. INDICATIONS FOR USE
510(k) Number (if known): K053110
Device Name: i-STAT CHEM8+ Cartridge
The i-STAT CHEM8+ Cartridge is useful for monitoring a variety of conditions. The FSTAT CHEMOT Outfination is assess kidney for every hidney function, The panel of tests is used in the noophal string and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Ann Chappie
Jivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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