IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)

K972861 · Instrumentation Laboratory CO · JJS · Aug 19, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972861
• Device Name: IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
• Applicant: Instrumentation Laboratory CO
• Product Code: JJS · Clinical Chemistry
• Decision Date: Aug 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with specific concentrations of carbon dioxide and oxygen and with a known level of sodium, potassium, calcium, chloride and glucose and available in three levels to simulate clinically significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/ K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.

Device Story

IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material; liquid-based; equilibrated with specific concentrations of CO2, O2, Na+, K+, Ca++, Cl-, and glucose. Used in clinical laboratories to verify instrument performance for blood gas, electrolyte, and oximetry analysis. Provided in three levels to simulate various clinical states of acid-base, electrolyte, and oxygenation balance. Healthcare providers use the control material to monitor instrument accuracy and precision; results are compared against expected values to ensure reliable patient testing. Benefits include quality assurance for diagnostic instrumentation, reducing risk of erroneous clinical decisions based on inaccurate laboratory data.

Clinical Evidence

Bench testing only. Performance data provided for three levels of the control material, reporting grand means and within-run precision (%CV) for all monitored parameters (pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, THb, COHb, O2Hb, MetHb, RHb).

Technological Characteristics

In vitro diagnostic quality control material; liquid-based; equilibrated with gases and electrolytes. Parameters monitored: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and hemoglobin fractions. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the performance of clinical laboratory instruments measuring pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and hemoglobin fractions (THb, O2Hb, COHb, MetHb, RHb) in patient samples.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• IL Test™ ContrIL PLUS (K963800)
• IL Test™ Multi-4 (K945677)

Submission Summary (Full Text)

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K972861

# AUG 1 9 1997

## SECTION 3 IL Test™ ContrIL Spectrum - 510(k) SUMMARY (Summary of Safety and Effectiveness)

#### Submitted by:

Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] Fax: [phone]

#### Contact persons:

Betty Lane Phone: [phone]

Carol Marble Alternate: [phone] Phone:

Class I

#### Summary prepared:

July 28, 1997

### Name of the device:

IL Test™ ContrIL Spectrum

#### Classification name(s):

| | 862.1660 Quality Control Material (Assayed and Unassayed) |
|-------|-----------------------------------------------------------|
| 75JJS | Controls for Blood-Gases (Assayed and Unassayed) |
| 75JJR | Electrolyte Controls (Assayed and Unassayed) |

#### Identification of predicate devices:

IL Test™ ContrIL PLUS for monitoring pH/pCO2/pO2/Na+/K+/Ca++/Cl-/Glucose K963800 IL Test™ Multi-4 (Levels 1, 2 and 4) for monitoring THb/O2Hb/COHb/MetHb/RHb K945677

#### Description of the device/intended use(s):

IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with specific concentrations of carbon dioxide and oxygen and with a known level of sodium, potassium, calcium, chloride and glucose and available in three levels to simulate clinically significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/ K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.

### Statement of how the technological characteristics of the device compared to the predicate device:

IL Test™ Spectrum is substantially equivalent in performance, intended use, safety and effectiveness to the predicate devices: IL Test™ ContrIL PLUS for monitoring pH/pCO2/pO2/ Na+/K+/Ca++/Cl-/Glucose and IL Test™ Multi-4 Control for monitoring THb/O2Hb/COHb/ MetHb/RHb.

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## SECTION 3 (Continued) IL Test™ ContrIL Spectrum - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Summary of performance data:

| | | Level 1 | | Level 2 | | Level 3 | |
|-------------|---------------|----------------------|---------------|----------------------|---------------|----------------------|--|
| Parameter | Grand<br>Mean | Within<br>Run<br>%CV | Grand<br>Mean | Within<br>Run<br>%CV | Grand<br>Mean | Within<br>Run<br>%CV | |
| pH | 7.59 | 0.03 | 7.41 | 0.02 | 7.13 | 0.03 | |
| pCO2 (mmHg) | 20.80 | 1.98 | 37.81 | 1.81 | 64.91 | 1.43 | |
| pO2 (mmHg) | 145.94 | 1.69 | 87.80 | 3.71 | 52.05 | 4.89 | |
| Na+ (mm/L) | 114.66 | 0.62 | 137.46 | 0.40 | 157.20 | 0.59 | |
| K+ (mm/L) | 2.57 | 2.93 | 4.33 | 1.65 | 5.99 | 1.04 | |
| Ca++ (mm/L) | 0.62 | 1.82 | 1.00 | 1.40 | 1.54 | 1.69 | |
| Cl- (mm/L) | 83.06 | 0.66 | 110.03 | 0.53 | 137.60 | 0.40 | |
| Glu (mg/dL) | 60.74 | 3.79 | 84.49 | 2.43 | 233.29 | 2.04 | |
| THb | 7.1 | 3.64 | 13.4 | 3.35 | 18.0 | 2.73 | |
| % COHb | 54.1 | 0.32 | 4.0 | 1.17 | 96.6 | 0.06 | |
| % O2Hb | 44.9 | 0.38 | 93.6 | 0.13 | 1.9 | 0 | |
| % MetHb | 0.5 | 3.21 | 1.8 | 5.77 | 1.5 | 5.30 | |
| % RHb | 0.5 | 1.85 | 0.6 | 3.86 | 0.002 | 4.40 | |

ﺳﺴﺴﺴﺴ

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 9 1997

Ms. Betty Lane Director Requlatory Affairs ···· Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173

Re : K972861 IL Test ContrIL Spectrum Requlatory Class: I Product Code: JJS Dated: August 1, 1997 Received: August 4, 1997

Dear Ms. Lane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference bo
premarket notification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

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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### Indications for Use Statement

510(k) Number (if known): _

-Device Name: IL Test™ ContrIL Spectrum -

### Indications for Use:

IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with specific concentrations of carbon dioxide and oxygen and with a known level of sodium, potassium, calcium, chloride and glucose and available in three levels to simulate clinically significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/ K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Veronica J. Colvin for A Montgomery |
|---------------|-----------------------------------------|
| | (Division Sign-Off) |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K972861 |

| Prescription Use<br>(Per 21 CFR 801.019) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

Section 2 IL Test™ ContrIL Spectrum 510(k) Page 1 of 1