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 Description

AI/ML Overview

The provided document is a 510(k) summary for the IL Test™ ContrIL Spectrum, an in vitro diagnostic quality control material. It describes the device's intended use and presents performance data. However, the document does not establish explicit "acceptance criteria" in the form of predefined performance thresholds that the device must meet.

Instead, the study presented is primarily a performance summary demonstrating the consistency and expected values of different analytes within the quality control material at various levels. The "acceptance" is implicitly based on showing that the control material consistently yields quantifiable results for the listed parameters with acceptable precision (indicated by %CV, Coefficient of Variation) across different levels. The 510(k) clearance process focuses on substantial equivalence to predicate devices, and the performance data supports this claim by showing similar performance characteristics.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria (e.g., "pH must be within X% of target" or "CV must be less than Y%") are not stated in the provided document. The table below presents the reported device performance for the IL Test™ ContrIL Spectrum for each measured parameter at three different levels. The "acceptance criteria" for a quality control material would typically relate to its ability to consistently produce specific, known values within a small range of variability, which is what the "Grand Mean" and "Within Run %CV" data demonstrate.

Parameter	Grand Mean (Level 1)	Within Run %CV (Level 1)	Grand Mean (Level 2)	Within Run %CV (Level 2)	Grand Mean (Level 3)	Within Run %CV (Level 3)
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+ (mmol/L)	114.66	0.62	137.46	0.40	157.20	0.59
K+ (mmol/L)	2.57	2.93	4.33	1.65	5.99	1.04
Ca++ (mmol/L)	0.62	1.82	1.00	1.40	1.54	1.69
Cl- (mmol/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

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of runs, number of vials, number of measurements) used to generate the "Within Run %CV" data. It reports "Grand Mean" and "Within Run %CV" for each parameter at three levels, which implies a series of measurements were taken, but the exact N is not provided.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a 510(k) submission from Instrumentation Laboratory Company based in Lexington, MA, USA, suggesting the study likely took place in the US or was overseen by the US-based company.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This device is a quality control material for laboratory instruments, not a diagnostic device that interprets patient data. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for imaging) does not apply here.
The reported "Grand Mean" values are derived from analytical measurements using laboratory instruments. The "ground truth" for the test set is established by the analytical methods and instrumentation used to determine the values and assess the precision of the control material. There is no mention of human experts in this context.

4. Adjudication Method for the Test Set

Since the "ground truth" is established by analytical measurements rather than expert human interpretation, there is no adjudication method described as would be relevant for subjective assessments (e.g., 2+1, 3+1). The "Grand Mean" and "Within Run %CV" are statistical calculations from direct measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance

No. This is a quality control material for laboratory instrumentation, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study with human readers (with or without AI assistance) is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a laboratory quality control material, not an algorithm or AI device. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance presented relates to the analytical capabilities of the quality control material itself when measured by laboratory instruments.

7. The Type of Ground Truth Used

The "ground truth" for this quality control material is established through analytical measurements using laboratory instruments. The "Grand Mean" for each parameter represents the assigned value for that specific level of control material, determined by rigorous laboratory procedures and validated instrumentation. The "Within Run %CV" indicates the precision around this established mean. It is essentially an "assigned value" based on a reference method or highly controlled measurement process.

8. The Sample Size for the Training Set

This device is a physical quality control material, not a machine learning model. Therefore, the concepts of a "training set" and "training set sample size" are not applicable. The data presented are performance characteristics of the manufactured control material.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for a machine learning model, this question is not applicable. The determination of the "Grand Mean" values for the quality control material would have been established during its manufacturing and characterization process, likely through extensive testing and calibration against reference standards, to ensure each lot has consistent and known values for the listed analytes.

Summary

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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: (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):

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	GrandMean	WithinRun%CV	GrandMean	WithinRun%CV	GrandMean	WithinRun%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

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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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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

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Indications for Use Statement

510(k) Number (if known): _

-Device Name: IL Test™ ContrIL Spectrum -

Indications for Use:

(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

Regulation Number and Section

§ 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.