Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

K053110 · I-Stat Corporation · JGS · Jan 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053110
• Device Name: Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
• Applicant: I-Stat Corporation
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended 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.

Device Story

i-STAT CHEM8+ Cartridges; single-use, in vitro diagnostic test cartridges for point-of-care blood analysis. Device combines multiple electrochemical sensors into a single cartridge to measure Sodium, Potassium, Chloride, Urea Nitrogen, Glucose, Hematocrit, Calcium, Creatinine, and Total CO2; calculates Anion Gap and Hemoglobin. Used by healthcare professionals in clinical settings to provide rapid diagnostic results from whole blood samples. Modification involves integrating electrode configurations from previously cleared i-STAT cartridges into a single platform. Output displayed on i-STAT analyzer; assists clinicians in rapid metabolic and electrolyte assessment.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that modifications to electrode configuration did not impact device performance or intended use.

Technological Characteristics

Single-use cartridge for use with i-STAT 1 Analyzer. Employs electrochemical sensing technology consistent with existing i-STAT cartridges. Factory-calibrated. Software-controlled analysis cycle. No specific materials or ASTM standards provided.

Indications for Use

Indicated for use by medical professionals to monitor kidney function, electrolyte balance, and blood sugar levels. Used to assess conditions including hypertension and hypokalemia in patients requiring quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit.

Regulatory Classification

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.

Predicate Devices

• i-STAT System (K894914)
• i-STAT System (K934642)
• i-STAT System (K936081)
• i-STAT System (K940918)
• i-STAT System (K973292)

Submission Summary (Full Text)

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ad V. J Mediany

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K053110

## 510(k) Summary

#### Applicant

i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Phone [phone] Fax [phone]

#### 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: [phone] • 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<br>DEVICE |
|-----------------|-----------------|-------------|-------------|--------------------|
| TEST/ANALYTE | i-STAT Crea | i-STAT CG8+ | i-STAT EC8+ | i-STAT<br>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 [phone]. 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 [phone] or [phone] 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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