The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

Device Description

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

AI/ML Overview

The ILab 600 Clinical Chemistry System is an automated, random access clinical chemistry analyzer that quantifies analytes in physiological fluids using photometry and potentiometry. The device was found substantially equivalent to the ILab 900/1800 Clinical Chemistry System (K932467, K943595) and IL Test assays (K943366, K952646, K943367, K952647).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ILab 600 are implicit in its claim of substantial equivalence to the predicate device, the ILab 900. This means the performance of the ILab 600 must be "statistically similar" to that of the ILab 900 across various analytes and sample types (serum, urine, cerebrospinal fluid).

The reported device performance is demonstrated through method comparison studies and precision studies.

Method Comparison Studies (ILab 600 vs. ILab 900):

IL Test	Units	n	Range	Slope (IL600 vs. IL900)	Intercept	r (Correlation Coefficient)
Serum Samples
Acid Phosp., Non-Prostatic	U/L	97	0.3-27.6	0.867	0.38	0.986
Acid Phosp., Total	U/L	94	0.4-33.4	0.957	0.197	0.996
Albumin	g/dL	98	2.9-5.5	1.047	-0.183	0.985
Alkaline Phosphatase	U/L	108	24-623	1.052	5.94	0.999
ALT/GPT	U/L	109	2-2557	1.006	-1.4	0.999
Amylase	U/L	110	25-377	1.040	0.1	0.997
AST/GOT	U/L	115	14-2377	1.065	0.1	0.998
Bilirubin, Direct	mg/dL	100	0.03-15.19	0.989	-0.029	0.999
Bilirubin, Total	mg/dL	99	0.02-26.52	0.955	0.034	0.999
Calcium	mg/dL	98	6.5-15.6	1.040	-0.028	0.990
Cholesterol	mg/dL	117	40-944	1.005	2.334	0.997
Cholinesterase	U/L	107	2166-12692	1.002	195.4	0.990
CK/CPK	U/L	103	18-3759	0.933	6.72	0.998
CK-MB	U/L	110	0.6-237.2	1.003	-1.4	0.997
Creatinine	mg/dL	99	0.8-7.1	1.029	0.147	0.998
Glucose Hexokinase	mg/dL	113	60-457	1.017	0.358	0.997
Glucose Oxidase	mg/dL	137	51-393	0.944	7.92	0.997
γ-GT	U/L	122	4-497	1.052	1.2	0.999
Iron	µg/dL	97	10-253	1.040	2.37	0.998
LD-L/LDH-L	U/L	95	45-404	0.997	3.56	0.992
Lipase	U/L	64	8-2719	0.972	-1.7	0.999
Magnesium	mg/dL	103	1.60-8.24	0.988	0.01	0.994
Phosphorus	mg/dL	100	2.5-11.3	0.976	0.06	0.998
TCO2	mmol/L	102	10-36	1.079	-1.43	0.987
Total Protein	g/dL	98	4.6-8.8	0.966	0.16	0.992
Triglycerides	mg/dL	96	37-1039	0.978	1.414	0.999
Urea Nitrogen	mg/dL	119	7.0-68.0	1.007	-0.015	0.998
Uric Acid	mg/dL	99	1.9-15.9	0.963	0.11	0.995
ISE Chloride	mmol/L	90	36.8-143.2	1.028	-1.39	0.998
ISE Potassium	mmol/L	79	2.0-7.3	1.013	-0.04	0.999
ISE Sodium	mmol/L	90	62.4-157.4	1.011	1.39	0.999
Urine Samples
Amylase	U/L	65	26-6068	0.953	-21	0.999
Calcium	mg/dL	70	20-92	0.923	-0.07	0.995
Creatinine	mg/dL	59	49-263	1.065	4.2	0.992
Glucose Hexokinase	mg/dL	95	4-690	1.027	2.55	0.996
Glucose Oxidase	mg/dL	80	0-801	0.949	4.29	0.997
Phosphorus	mg/dL	60	36-161	0.953	-2.3	0.980
Urea Nitrogen	mg/dL	58	200-1649	1.060	13.7	0.992
Uric Acid	mg/dL	70	9-91	0.989	1.84	0.997
ISE Chloride	mmol/L	50	73-249	1.042	-5.74	0.998
ISE Potassium	mmol/L	49	19-85	1.083	-1.3	0.999
ISE Sodium	mmol/L	49	73-194	1.000	5.36	0.999
Cerebrospinal Fluid Samples
Glucose Oxidase	mg/dL	20	40-226	0.932	-0.117	1.000

Precision Studies (ILab 600):

Serum Samples: Two levels of serum samples (three for Cholesterol) were tested in triplicate twice a day for 10 days (n=60 total). The Total %CV for most analytes was generally low, indicating good precision. For example:
- Albumin: Level 1 (1.79%), Level 2 (1.08%)
- ALT/GPT: Level 1 (1.26%), Level 2 (0.99%)
- Cholesterol: Level 1 (2.11%), Level 2 (1.35%), Level 3 (1.37%)
- ISE Sodium: Level 1 (0.94%), Level 2 (0.67%)
Urine Samples: Two levels of urine samples were tested in triplicate twice a day for 10 days (n=60 total). Similar to serum, Total %CV remained low:
- Amylase: Level 1 (2.56%), Level 2 (2.02%)
- Creatinine: Level 1 (2.11%), Level 2 (1.73%)
- ISE Sodium: Level 1 (1.13%), Level 2 (0.65%)
Cerebrospinal Fluid Samples: Two levels of CSF samples were tested using IL Test Glucose Oxidase in triplicate twice a day for 5 days (n=30 total).
- Glucose Oxidase: Level 1 (1.49%), Level 2 (0.98%)

The studies conclude that the ILab 600 and ILab 900 are "statistically similar" for the tests evaluated. The precision studies demonstrate acceptable levels of reproducibility based on the reported Coefficient of Variation (%CV) values for within-run, among-run, among-day, and total precision. No specific numerical thresholds for acceptance criteria were explicitly stated, but the robust statistical similarity and low %CV values imply the device meets the necessary performance standards for clinical use.

2. Sample Sizes and Data Provenance

Test Set (Method Comparison):
- Serum Samples: Sample sizes ranged from a minimum of 64 (Lipase) to a maximum of 137 (Glucose Oxidase).
- Urine Samples: Sample sizes ranged from 49 (ISE Potassium and Sodium) to 95 (Glucose Hexokinase).
- Cerebrospinal Fluid Samples: Sample size was 20 (Glucose Oxidase).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
Test Set (Precision Studies):
- Serum Samples: n=60 for most analytes (triplicate measurements, twice a day, for 10 days). Cholesterol used n=60 across three levels.
- Urine Samples: n=60 for all analytes (triplicate measurements, twice a day, for 10 days).
- Cerebrospinal Fluid Samples: n=30 for Glucose Oxidase (triplicate measurements, twice a day, for 5 days).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document pertains to the performance characteristics of a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" in this context refers to the actual concentration of the analytes in the samples. Clinical chemistry analyzer performance is typically evaluated by comparing results to a reference method (in this case, the predicate device ILab 900) or by using certified reference materials with known concentrations. Therefore, expert interpretation or consensus, as might be used in image-based diagnostic AI, is not applicable here. No mention of human experts defining "ground truth" is provided or expected.

4. Adjudication Method

Not applicable. As described in point 3, this is a quantitative measurement device, not an interpretation task requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is a clinical chemistry analyzer, not an AI system assisting human readers in diagnostic interpretation. The study evaluates the analyzer's performance directly against a predicate device and for precision, not the human reader's effectiveness with or without AI.

6. Standalone Performance Study

Yes, standalone performance was done.

Method Comparison Studies: The performance of the ILab 600 was compared directly to that of the ILab 900 (predicate device). This is a standalone comparison of the new device against an established one.
Precision Studies: The precision of the ILab 600 was evaluated independently, measuring its reproducibility across different runs and days. This is also a standalone performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for these studies is the quantitative analytical result obtained from the predicate device (ILab 900) for method comparison studies, and the inherent, measured concentration within the biological samples for precision studies. This is a form of reference method comparison or analytical accuracy assessment, rather than pathology, expert consensus, or outcomes data, which are typically associated with qualitative or interpretative diagnostics. For precision, the ground truth is implicitly the true, stable concentration in the control/patient samples being repeatedly measured.

8. Sample Size for the Training Set

Not applicable. The ILab 600 is a clinical chemistry analyzer, which operates based on established chemical and photometric/potentiometric principles and internal calibration curves. It is not an AI/ML device that requires a "training set" in the sense of supervised learning. Its analytical methods are pre-programmed and validated, not learned from data in the way a machine learning algorithm would be.

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

Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design and standard laboratory calibration procedures, not through a data-driven training process.

Summary

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KL980757

APR 2 | 1998

SECTION 3

ILab 600 Clinical Chemistry System - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:

Contact person:

Carol Marble Phone: (781) 861-4467

Summary prepared:

February 26, 1998

Name of the device:

ILab 600 Clinical Chemistry System

Classification name(s):

CFR Ref.	Description	Class
862.2300	Colorimeter, photometer or spectrophotometer for clinical use(75JJQ Colorimeter, photometer, spectrophotometer for clinical use)	I
862.2500	Enzyme analyzer for clinical use(75JJI Analyzer, enzyme, for clinical use)	I
862.1020	Acid phosphatase (total or prostatic) test system	II
862.1030	Alanine amino transferase (ALT/SGPT) test system	I
862.1035	Albumin test system	II
862.1050	Alkaline phosphatase or isoenzymes test system	II
862.1070	Amylase test system	II
862.1100	Aspartate amino transferase (AST/SGOT) test system	II
862.1110	Bilirubin (total or direct) test system	II
862.1145	Calcium test system	II
862.1150	Calibrator	II
862.1160	Bicarbonate/carbon dioxide test system	II
862.1170	Chloride (total) test system	I
862.1175	Cholesterol	I
862.1210	Creatine test system	II
862.1215	Creatine phosphokinase/creatine kinase or isoenzymes test system	II

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Classification name(s) (Continued)

CFR Ref.	Description	Class
862.1225	Creatinine test system	II
862.1345	Glucose test system	I
862.1360	Gamma-glutamyl transpeptidase and isoenzymes test system	I
862.1410	Iron (non-heme) test system	I
862.1440	Lactate dehydrogenase test system	II
862.1465	Lipase test system	I
862.1495	Magnesium test system	I
862.1580	Phosphorus (inorganic) test system	I
862.1600	Potassium test system	II
862.1635	Total protein test system	II
862.1660	Quality control material (assayed and unassayed)	I
862.1665	Sodium test system	II
862.1705	Triglyceride test system	I
862.1770	Urea nitrogen test system	I
862.1775	Uric acid test system	I
862.3240	Cholinesterase test system	I

Identification of predicate device(s):

K932467	ILab 900/1800 Clinical Chemistry System
K943595	ILab 900/1800 Clinical Chemistry System - Urine Claims Added
K943366	IL Test Acid Phosphatase
K952646	IL Test CK-MB
K943367	IL Test Cholinesterase

IL Test Lipase K952647

Description of the device/intended use(s):

Statement of how the Technological Characteristics of the Device compare to the Predicate Device:

The ILab 600 uses the same technology as the ILab 900 and is substantially equivalent in performance, intended use, safety and effectiveness. The ILab 900 maintain the same reagent temperature, use the same reagent formulations and the same applications (proportional volumes). The ISE module on the ILab 600 is also very similar to that of the ILab 900 (predicate device); the same electrodes and solutions are utilized as is the same type of reaction mechanism.

Main differences:	ILab 600	ILab 900
• Throughput	Medium (400 tests/hour)	High (600 tests/hour)
• Optical Path Length	5 mm	6 mm
• Operating System	Windows NT	In-house Developed
• Reagent Volume	20-400 µL	50-600 µL

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Summary of performance data:

Method Comparison Studies

In method comparison studies evaluating serum samples, the ILab 600 and the ILab 900 (predicate device) were shown to be statistically similar for the tests listed below.

IL Test	Units	n	Range	Slope	Intercept	r
Acid Phosp., Non-Prostatic	U/L	97	0.3-27.6	0.867	0.38	0.986
Acid Phosp., Total	U/L	94	0.4-33.4	0.957	0.197	0.996
Albumin	g/dL	98	2.9-5.5	1.047	-0.183	0.985
Alkaline Phosphatase	U/L	108	24-623	1.052	5.94	0.999
ALT/GPT	U/L	109	2-2557	1.006	-1.4	0.999
Amylase	U/L	110	25-377	1.040	0.1	0.997
AST/GOT	U/L	115	14-2377	1.065	0.1	0.998
Bilirubin, Direct	mg/dL	100	0.03-15.19	0.989	-0.029	0.999
Bilirubin, Total	mg/dL	99	0.02-26.52	0.955	0.034	0.999
Calcium	mg/dL	98	6.5-15.6	1.040	-0.028	0.990
Cholesterol	mg/dL	117	40-944	1.005	2.334	0.997
Cholinesterase	U/L	107	2166-12692	1.002	195.4	0.990
CK/CPK	U/L	103	18-3759	0.933	6.72	0.998
CK-MB	U/L	110	0.6-237.2	1.003	-1.4	0.997
Creatinine	mg/dL	99	0.8-7.1	1.029	0.147	0.998
Glucose Hexokinase	mg/dL	113	60-457	1.017	0.358	0.997
Glucose Oxidase	mg/dL	137	51-393	0.944	7.92	0.997
γ-GT	U/L	122	4-497	1.052	1.2	0.999
Iron	µg/dL	97	10-253	1.040	2.37	0.998
LD-L/LDH-L	U/L	95	45-404	0.997	3.56	0.992
Lipase	U/L	64	8-2719	0.972	-1.7	0.999
Magnesium	mg/dL	103	1.60-8.24	0.988	0.01	0.994
Phosphorus	mg/dL	100	2.5-11.3	0.976	0.06	0.998
TCO2	mmol/L	102	10-36	1.079	-1.43	0.987
Total Protein	g/dL	98	4.6-8.8	0.966	0.16	0.992
Triglycerides	mg/dL	96	37-1039	0.978	1.414	0.999
Urea Nitrogen	mg/dL	119	7.0-68.0	1.007	-0.015	0.998
Uric Acid	mg/dL	99	1.9-15.9	0.963	0.11	0.995
ISE Chloride	mmol/L	90	36.8-143.2	1.028	-1.39	0.998
ISE Potassium	mmol/L	79	2.0-7.3	1.013	-0.04	0.999
ISE Sodium	mmol/L	90	62.4-157.4	1.011	1.39	0.999
IL Test	Units	n	Range	Slope	Intercept	r
Amylase	U/L	65	26-6068	0.953	-21	0.999
Calcium	mg/dL	70	20-92	0.923	-0.07	0.995
Creatinine	mg/dL	59	49-263	1.065	4.2	0.992
Glucose Hexokinase	mg/dL	95	4-690	1.027	2.55	0.996
Glucose Oxidase	mg/dL	80	0-801	0.949	4.29	0.997
Phosphorus	mg/dL	60	36-161	0.953	-2.3	0.980
Urea Nitrogen	mg/dL	58	200-1649	1.060	13.7	0.992
Uric Acid	mg/dL	70	9-91	0.989	1.84	0.997
ISE Chloride	mmol/L	50	73-249	1.042	-5.74	0.998
ISE Potassium	mmol/L	49	19-85	1.083	-1.3	0.999
ISE Sodium	mmol/L	49	73-194	1.000	5.36	0.999

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Method Comparison Studies (Continued)

In method comparison studies evaluating urine samples, the ILab 600 and the ILab 900 (predicate device) were shown to be statistically similar for the tests listed below.

In a method comparison study evaluating cerebrospinal fluid samples, the ILab 600 and the ILab 900 (predicate device) were shown to be statistically similar for the test shown below.

IL Test	Units	n	Range	Slope	Intercept	r
Glucose Oxidase	mg/dL	20	40 - 226	0.932	-0.117	1.000

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Precision Studies

Two levels of serum samples (except IL Test Cholesterol which used three) were tested in triplicate I wo levels of berail banking to runs total, n=60) on an ILab 600 Clinical Chemistry System. The results are given below. and the same of the same of the same of the same of the states of the states and

IL Test	SerumSample	Mean	Within Run%CV	Among Run%CV	Among Day%CV	Total%CV
Acid Phos., NP	Level 1	1.51 U/L	8.51	3.24	7.01	11.49
Acid Phos., NP	Level 2	1.75 U/L	9.61	0.00	6.64	11.68
Acid Phos., Total	Level 1	1.9 U/L	5.78	0.00	7.89	9.78
Acid Phos., Total	Level 2	2.5 U/L	4.85	0.00	6.22	7.89
Albumin	Level 1	2.4 g/dL	1.69	0.38	0.44	1.79
Albumin	Level 2	4.1 g/dL	1.00	0.41	0.00	1.08
Alk. Phosphatase	Level 1	43 U/L	3.73	3.43	3.94	6.42
Alk. Phosphatase	Level 2	187 U/L	1.28	2.78	1.46	3.40
ALT/GPT	Level 1	53 U/L	0.91	0.87	0.00	1.26
ALT/GPT	Level 2	101 U/L	0.64	0.37	0.66	0.99
Amylase	Level 1	45 U/L	1.51	0.71	0.00	1.67
Amylase	Level 2	149 U/L	0.97	0.23	0.42	1.08
AST/GOT	Level 1	25 U/L	2.28	3.00	0.72	3.83
AST/GOT	Level 2	52 U/L	0.97	0.74	0.00	1.22
Bilirubin, Direct	Level 1	0.18 mg/dL	2.72	5.51	6.98	9.30
Bilirubin, Direct	Level 2	2.12 mg/dL	0.86	2.31	3.51	4.29
Bilirubin, Total	Level 1	0.54 mg/dL	2.62	4.70	3.94	6.72
Bilirubin, Total	Level 2	3.70 mg/dL	0.45	0.81	1.13	1.46
Calcium	Level 1	9.0 mg/dL	1.27	0.00	0.66	1.43
Calcium	Level 2	13.6 mg/dL	1.00	0.00	0.72	1.23
Cholesterol	Level 1	94 mg/dL	1.66	1.30	0.00	2.11
Cholesterol	Level 2	175 mg/dL	1.31	0.00	0.36	1.35
Cholesterol	Level 3	207 mg/dL	0.92	0.68	0.76	1.37
Cholinesterase	Level 1	2399 U/L	0.52	1.17	6.00	6.13
Cholinesterase	Level 2	7078 U/L	0.76	1.42	6.06	6.27
CK/CPK	Level 1	109 U/L	1.95	1.70	2.07	3.31
CK/CPK	Level 2	368 U/L	1.98	2.94	4.28	5.56
CK-MB	Level 1	25.2 U/L	2.74	7.38	4.44	9.04
CK-MB	Level 2	99.2 U/L	1.08	3.61	2.57	4.56
Creatinine	Level 1	1.0 mg/dL	4.53	0.00	1.51	4.70
Creatinine	Level 2	4.3 mg/dL	1.29	0.25	0.81	1.54
Glu. Hexokinase	Level 1	83 mg/dL	0.87	0.20	0.28	0.93
Glu. Hexokinase	Level 2	263 mg/dL	0.72	0.37	0.00	0.81
Glucose Oxidase	Level 1	73 mg/dL	1.31	0.00	0.75	1.51
Glucose Oxidase	Level 2	248 mg/dL	0.75	0.44	0.34	0.94
γ-GT	Level 1	19 U/L	1.53	1.05	0.97	2.09
γ-GT	Level 2	123 U/L	0.93	0.41	0.24	1.05
Iron	Level 1	129 µg/dL	0.71	0.00	0.57	0.91
Iron	Level 2	193 µg/dL	0.75	0.40	0.85	1.20
LD-L/LDH-L	Level 1	141 U/L	1.67	0.86	1.69	2.53
LD-L/LDH-L	Level 2	442 U/L	1.79	0.66	1.25	2.28
	Serum		Within Run	Among Run	Among Day	Total
IL Test	Sample	Mean	%CV	%CV	%CV	%CV
	Level 1	19 U/L	9.48	0.00	5.06	10.74
Lipase	Level 2	352 U/L	0.84	0.00	2.18	2.34
	Level 1	1.86 mg/dL	1.15	3.40	0.00	3.58
Magnesium	Level 2	5.06 mg/dL	0.90	2.23	2.04	3.16
	Level 1	3.45 mg/dL	1.45	0.00	0.61	1.57
Phosphorus	Level 2	6.44 mg/dL	0.98	0.53	0.00	1.12
	Level 1	14.92 mmol/L	3.12	0.00	3.30	4.54
TCO2	Level 2	30.80 mmol/L	1.26	0.87	2.10	2.60
	Level 1	3.8 g/dL	1.13	0.00	0.44	1.21
Total Protein	Level 2	6.9 g/dL	0.98	0.00	0.38	1.05
	Level 1	64 mg/dL	1.48	2.61	3.18	4.37
Triglycerides	Level 2	197 mg/dL	0.77	0.91	1.66	2.04
	Level 1	15.7 mg/dL	1.05	2.15	5.30	5.82
Urea Nitrogen	Level 2	53.6 mg/dL	0.79	1.59	4.26	4.62
	Level 1	3.3 mg/dL	1.17	3.37	0.48	3.60
Uric Acid	Level 2	7.9 mg/dL	0.77	1.53	0.57	1.80
	Level 1	83.00 mmol/L	0.69	1.26	0.24	1.45
ISE Chloride	Level 2	108.67 mmol/L	0.46	0.58	0.00	0.74
	Level 1	4.18 mmol/L	1.16	0.00	0.52	1.27
ISE Potassium	Level 2	7.20 mmol/L	0.41	0.69	0.77	1.11
	Level 1	130 mmol/L	0.70	0.38	0.50	0.94
ISE Sodium	Level 2	150 mmol/L	0.53	0.20	0.36	0.67

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Precision Studies (Continued)

Two levels of urine samples were tested in triplicate twice a day for 10 days (20 runs total, n=60) on an ILab 600 Clinical Chemistry System. The results are given below.

IL Test	UrineSample	Mean	Within Run%CV	Among Run%CV	Among Day%CV	Total%CV
Amylase	Level 1	139.0 U/L	1.89	1.20	1.26	2.56
Amylase	Level 2	410.0 U/L	1.49	1.00	1.10	2.02
Calcium	Level 1	3.9 mg/dL	2.58	0.00	2.19	3.18
Calcium	Level 2	5.9 mg/dL	1.67	1.32	1.50	2.50
Creatinine	Level 1	71.6 mg/dL	1.40	0.00	1.58	2.11
Creatinine	Level 2	108.0 mg/dL	1.11	0.00	1.33	1.73
Glu. Hexokinase	Level 1	63.0 mg/dL	1.78	1.82	2.28	3.41
Glu. Hexokinase	Level 2	223.0 mg/dL	1.88	0.00	1.28	2.28
Glucose Oxidase	Level 1	56.0 mg/dL	1.38	1.18	1.85	2.60
Glucose Oxidase	Level 2	201.0 mg/dL	1.32	1.14	0.76	1.91
Phosphorus	Level 1	41.5 mg/dL	2.20	0.92	0.00	2.38
Phosphorus	Level 2	59.0 mg/dL	1.77	0.00	1.41	2.26
Urea Nitrogen	Level 1	493.0 mg/dL	1.49	0.00	0.78	1.68
Urea Nitrogen	Level 2	964.0 mg/dL	1.17	0.43	0.87	1.52
Uric Acid	Level 1	16.2 mg/dL	2.75	0.00	5.69	6.32
Uric Acid	Level 2	28.5 mg/dL	1.92	0.00	2.36	3.05

Section 3

" مستعمانية"

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Precision Studies (Continued)

IL Test	UrineSample	Mean	Within Run%CV	Among Run%CV	Among Day%CV	Total%CV
ISE Chloride	Level 1	105.0 mmol/L	0.35	0.84	0.19	0.93
ISE Chloride	Level 2	203.0 mmol/L	0.44	0.55	0.75	1.03
ISE Potassium	Level 1	25.8 mmol/L	0.26	0.54	1.69	1.79
ISE Potassium	Level 2	70.0 mmol/L	0.44	1.02	2.42	2.66
ISE Sodium	Level 1	95.0 mmol/L	0.38	0.43	0.97	1.13
ISE Sodium	Level 2	166.0 mmol/L	0.37	0.20	0.50	0.65

Two levels of cerebrospinal fluid samples were tested in triplicate twice a day for 5 days (10 runs total, n=30) using IL Test Glucose Oxidase on an ILab 600 Clinical Chemistry System. The results are given below.

IL Test	CSFSample	Mean	Within Run%CV	Among Run%CV	Among Day%CV	Total%CV
	Level 1	45.5 mg/dL	1.50	0.47	0.00	1.49
Glucose Oxidase	Level 2	90.3 mg/dL	0.77	0.46	0.45	0.98

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Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 21 1998

Carol Marble . Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue 02173-3190 Lexington, Massachusetts

Re : K980757 ILab™ 600 Clinical Chemistry System Requlatory Class: II CGZ, CEK, CEM, CFJ, CFR, CGA, CGS, CGX, Product Code: CIC, CIG, CIT, CIX, CJE, CKB, DIH, JFJ, JGJ, JGS, JIX, JJW, JJX, JJY, KHS Dated: February 26, 1998 February 27, 1998 Received:

Dear Ms. Marble:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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 to 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" a

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): K980757

Device Name: ILab 600 Clinical Chemistry System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K980757

Prescription Use(Per 21 CFR 801.019)	OR	Over-The-Counter Use
------------------------------------------	----	----------------------

Section 2
ILab 600 510(k)
Page 1 of 1

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.