(15 days)
No
The device is a quality control material, not a diagnostic or analytical device that would typically incorporate AI/ML for data processing or interpretation. The description focuses on the chemical composition and intended use for calibrating other instruments.
No
This device is an in vitro diagnostic quality control material, not a therapeutic device. It is used to monitor parameters, not to treat or alleviate a medical condition.
No
This device is described as an "in vitro diagnostic quality control material," meaning it is used to check the performance of diagnostic devices, rather than being a diagnostic device itself.
No
The device is described as an "in vitro diagnostic quality control material," which is a physical substance used to verify the accuracy of laboratory tests. This is a hardware component, not software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" and "Device Description" sections both explicitly state that "IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material".
- Purpose: The device is used to monitor various parameters (pH, pCO2, pO2, electrolytes, glucose, hemoglobin derivatives) which are measured in vitro (outside the body) using diagnostic instruments.
- Quality Control Material: It is described as a "quality control material," which is a common type of IVD used to verify the accuracy and precision of diagnostic tests.
Therefore, the text clearly identifies this device as an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
75JJS, 75JJR
Device Description
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.
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
| Parameter | Grand Mean | Within Run %CV | Grand Mean | Within Run %CV | Grand Mean | Within Run %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 |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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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: (617) 861-4182 Fax: (617) 861-4464
Contact persons:
Betty Lane Phone: (617) 861-4182
Carol Marble Alternate: (617) 861-4467 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.
1
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 | ||||||
| Mean | Within | ||||||
| Run | |||||||
| %CV | Grand | ||||||
| Mean | Within | ||||||
| Run | |||||||
| %CV | Grand | ||||||
| Mean | Within | ||||||
| Run | |||||||
| %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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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized graphic of a person in motion, possibly running or jumping, with three curved lines representing movement. To the left of the graphic, the words "DEPARTMENT OF HEALTH" are arranged vertically, with the word "OF" stacked between "DEPARTMENT" and "HEALTH". The text is in a sans-serif font and is smaller than the graphic.
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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Page 2
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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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
| (Per 21 CFR 801.019) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Section 2 IL Test™ ContrIL Spectrum 510(k) Page 1 of 1