Predicate Devices

K932467, K943595, K943366, K952646, K943367, K952647

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard clinical chemistry analyzer using established analytical techniques (photometry and potentiometry) and does not mention any AI/ML terms or concepts.

Therapeutic

No
The device is described as a clinical chemistry analyzer used for in vitro quantitation of analytes in physiological fluids, with results used as "medical diagnostic tools," indicating it is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The results of the measurements are used as medical diagnostic tools."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry)". This indicates the device includes hardware components for performing these analytical techniques, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The description explicitly states that the ILab 600 is used for the "in vitro quantitation of analytes found in physiological fluids" and that "The results of the measurements are used as medical diagnostic tools." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description reiterates the in vitro nature of the analysis ("in vitro quantitation of analytes found in physiological fluids").

The core function of analyzing biological samples outside the body for diagnostic purposes is the defining characteristic of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

75JJQ, 75JJI, 862.1020, 862.1030, 862.1035, 862.1050, 862.1070, 862.1100, 862.1110, 862.1145, 862.1150, 862.1160, 862.1170, 862.1175, 862.1210, 862.1215, 862.1225, 862.1345, 862.1360, 862.1410, 862.1440, 862.1465, 862.1495, 862.1580, 862.1600, 862.1635, 862.1660, 862.1665, 862.1705, 862.1770, 862.1775, 862.3240, CGZ, CEK, CEM, CFJ, CFR, CGA, CGS, CGX, CIC, CIG, CIT, CIX, CJE, CKB, DIH, JFJ, JGJ, JGS, JIX, JJW, JJX, JJY, KHS

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.

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

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, with 'n' varying from 94 to 117.
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.
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 Glucose Oxidase, with n=20.

Precision Studies:
Two levels of serum samples (except IL Test Cholesterol which used three) were tested in triplicate twice a day for 10 days (20 runs total, n=60) on an ILab 600 Clinical Chemistry System.
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.
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.

Key Metrics

Method Comparison Studies:
For each IL Test, data is provided for Units, n, Range, Slope, Intercept, and r (correlation coefficient).
For example, Acid Phosphatase, Non-Prostatic in serum: n=97, Range 0.3-27.6, Slope 0.867, Intercept 0.38, r=0.986.
For Glucose Oxidase in cerebrospinal fluid: n=20, Range 40-226, Slope 0.932, Intercept -0.117, r=1.000.

Precision Studies:
For each IL Test and sample level, data is provided for Mean, Within Run %CV, Among Run %CV, Among Day %CV, and Total %CV.
For example, Acid Phos., NP Level 1 serum sample: Mean 1.51 U/L, Within Run %CV 8.51, Among Run %CV 3.24, Among Day %CV 7.01, Total %CV 11.49.
For Glucose Oxidase Level 1 CSF sample: Mean 45.5 mg/dL, Within Run %CV 1.50, Among Run %CV 0.47, Among Day %CV 0.00, Total %CV 1.49.

Predicate Device(s)

K932467, K943595, K943366, K952646, K943367, K952647

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

1

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):

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.

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

2

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

3

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

4

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

5

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 | Urine
Sample | 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"

6

Precision Studies (Continued)

| IL Test | Urine
Sample | 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 | CSF
Sample | 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 |

7

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.

8

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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 (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:

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.

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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
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ILab 600 510(k)
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