Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on automation of laboratory processes (pipetting, diluting, incubating, color intensity analysis) and does not mention AI or ML. The performance studies are standard for laboratory assays and do not indicate the use of AI/ML algorithms for result interpretation or analysis beyond basic color intensity measurement.

Therapeutic

No

The device is an automated laboratory instrument used for in vitro diagnostic testing, specifically for detecting IgG antibodies to rubella. It aids in assessing immunological response and determining immune status, which are diagnostic purposes, not therapeutic (treatment) ones.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic clinical use" and describes its purpose in aiding "in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals," as well as helping "in the diagnosis of current or recent infection with rubella."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "automated laboratory instrument" designed to automate the processing of assays, indicating it is a hardware device with integrated software for control and analysis.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states "for in vitro diagnostic clinical use". It describes the device's role in processing FDA-cleared enzyme-linked immunoabsorbent assays (EIA) and immunofluorescence assay (IFA) slides, which are common techniques used in in vitro diagnostics.
Device Description: The device is described as an "automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides." This aligns with the function of instruments used in clinical laboratories for in vitro diagnostic testing.
Intended User / Care Setting: The intended user is described as an "Automated laboratory instrument for in vitro diagnostic clinical use," further reinforcing its role in a clinical laboratory setting for diagnostic purposes.
Performance Studies: The performance studies describe testing performed with "Rubella IgG," which is a common analyte measured in clinical laboratories for diagnostic purposes related to rubella infection and immunity. The studies also mention using "patient samples" and comparing results to manual methods and a "Comparator," all indicative of clinical validation for diagnostic use.

The device is designed to automate the processing of assays that are themselves used for in vitro diagnostic purposes (detecting antibodies in human serum to aid in diagnosis and assessment of immune status). Therefore, the MAGO 4S Automated EIA and IFA Processor, as described, is an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.

The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

Product codes (comma separated list FDA assigned to the subject device)

LFX, JJF

Device Description

The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Precision/Reproducibility: For Precision, there were 6 well characterized samples (Diamedix QC Panels) run; two were negative and the other four spanned the reportable range of the Diamedix test kit. Comparable results were obtained from testing these samples manually versus testing them on the MAGO 4S. For reproducibility, three positive normal samples were selected and diluted to adjust their value to be near 10 IU/ml (slightly positive), per the CLSI standard. Test results showed that 3 standard deviations of all data for each sample was 20 IU/ml range were assayed. A total of two hundred and eight sera were tested once manually and once on the Mago 4S. Equivocal results are excluded from calculations. An assessment of Equivocal Zone was subsequently performed, and each kit was tested on the MAGO 4S and manually against the approximately 20 patient samples which were earlier identified in a retest zone (having originally tested manually between 7 and 13 IU/ml). The results showed that there was a single sample mean that indicated positive (≥ 10 IU/ml) on the manual test and indicated

Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.

Summary

0

K093101

JAN 2 1 2011

2. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Diamedix Corporation
TRADE NAME:	MAGO 4S
COMMON NAME:	MicroChemistry Analyzer
CLASSIFICATION NAME:	Micro Chemistry Analyzer for Clinical Use
DEVICE
CLASSIFICATION:	Class II, 866.3510 (Rubella virus serological reagents)
PRODUCT CODE:	LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
JJF
PANEL:	Virology (81)
PREDICATE DEVICES:	PhD System, Bio-Rad Laboratories (Class I, 510(k) exempt

Note: The instrument performance assessment in this submission is based on both the performance data in the original Rubella submission (K981729) and the requested data described in the performance section below.

Description of the Device Subject to Premarket Notification:

The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.

Intended Use:

For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.

The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

1

Technical Characteristics:

The MAGO 4S Automated EIA and IFA Processor has similar physical and technical characteristics to the predicate device.

Basis for Determination of Substantial Equivalence:

Upon reviewing the information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the MAGO 4S Automated EIA and IFA Processor is determined by Diamedix, to be substantially equivalent to existing legally marketed devices.

Performance Data:

All necessary verification and validation testing has been performed for the MAGO 4S Automated EIA and IFA Processor to assure substantial equivalence to the predicate devices. Specifically the following tests were performed with Rubella IgG: Precision/ Reproducibility, Linearity/Reportable range (where the strong positive and weak positive samples were diluted seven times at evenly spaced intervals), Positive and Negative Agreement with Comparator and Assessment of Equivocal Zone, CDC Performance Panel, and the CDC Biological Standard.

1. Precision/Reproducibility: For Precision, there were 6 well characterized samples (Diamedix QC Panels) run; two were negative and the other four spanned the reportable range of the Diamedix test kit. Comparable results were obtained from testing these samples manually versus testing them on the MAGO 4S. For reproducibility, three positive normal samples were selected and diluted to adjust their value to be near 10 IU/ml (slightly positive), per the CLSI standard. Test results showed that 3 standard deviations of all data for each sample was 200 are shown as blanks, no statistics were possible. When low results are reported on an analyte, a high coefficient of variation (CV) may result. (Taken from CAP survey)

| Site 2 Precision
Intra Assay
CV % | Day | QC A
Run 1 | QC A
Run 2 | QC B
Run 1 | QC B
Run 2 | QC C
Run 1 | QC C
Run 2 | QC D
Run 1 | QC D
Run 2 | QC E
Run 1 | QC E
Run 2 | QC F
Run 1 | QC F
Run 2 |
|-----------------------------------------|-----|------- | | 1 | 35.36% | | 2 | 30.74% | | 3 | 18.45% | | 4 | 18.45% | | 5 | 22.33% | | 6 | 35.36% | | 7 | 20.20% | | 8 | 20.20% | | 9 | 31.43% | | 10 | 23.57% | | 11 | 30.74% | | 12 | 30.74% | | 13 | 47.14% | | 14 | 30.74% | | 15 | 18.45% | | 16 | 23.57% | | 17 | 16.97% | | 18 | 30.74% | | 19 | 10.88% | | 20 | 28.28% | Interassay
Mean | | 1.026 | | Interassay
SD | | 0.288 | | Interassay
CV% | | 28.11% | --------|---------------|---------------|---------------|---------------|---------------|---------------|---------------|---------------|---------------|---------------|---------------|
| 40.41% | 0.00% | 60.61% | 4.54% | 5.33% | 3.60% | 6.04% | 2.82% | 2.74% | | 1.17% |
| 22.33% | 25.71% | 60.61% | 3.63% | 8.67% | 12.99% | 6.61% | 0.80% | 1.60% | | 5.43% |
| 62.85% | 28.28% | 25.71% | 4.40% | 3.11% | 5.74% | 5.13% | 0.38% | 6.03% | 2.90% | 1.01% |
| 28.28% | 26.19% | 22.33% | 5.01% | 8.07% | 9.12% | 8.47% | 0.84% | 4.51% | | |
| 28.28% | 28.28% | 37.22% | 13.42% | 11.45% | 9.90% | 5.94% | 4.49% | 0.54% | | 1.88% |
| 32.64% | 106.07% | 10.88% | 3.45% | 1.98% | 9.76% | 7.68% | 2.47% | 1.46% | | |
| 31.43% | 17.68% | 54.39% | 8.55% | 2.18% | 6.38% | 6.11% | 0.39% | 5.45% | 0.87% | 1.52% |
| 42.43% | 23.57% | 47.14% | 6.76% | 3.37% | 12.82% | 3.35% | 3.55% | 1.13% | | |
| 33.67% | 31.43% | 30.74% | 2.95% | 3.21% | 3.40% | 10.17% | 0.00% | 2.23% | | |
| 25.71% | 20.20% | 31.43% | 6.04% | 0.47% | 7.24% | 10.24% | | 2.11% | | |
| 28.28% | 43.89% | 23.57% | 1.39% | 4.96% | 5.24% | 6.31% | 1.37% | 3.33% | | |
| 43.51% | 21.76% | 32.64% | 7.58% | 9.24% | 23.13% | 6.34% | 2.05% | | | |
| 18.45% | 41.59% | 58.23% | 9.19% | 8.79% | 4.30% | 11.74% | 6.45% | 0.68% | 2.00% | 2.23% |
| 38.57% | 35.36% | 56.57% | 6.07% | 1.36% | 5.39% | 7.84% | 1.10% | 3.07% | | 0.00% |
| 37.22% | 20.20% | 41.59% | 0.00% | 2.50% | 13.83% | 8.07% | 2.29% | 2.80% | | |
| 14.14% | 47.14% | 37.22% | 6.50% | 0.60% | 2.93% | 4.64% | 6.22% | 8.06% | | 0.00% |
| 33.67% | 28.28% | 42.43% | 1.59% | 6.19% | 2.54% | 4.50% | 0.90% | 6.91% | | |
| 35.36% | 47.14% | 64.28% | 5.19% | 14.18% | 5.10% | 1.68% | 1.70% | 2.53% | | 2.33% |
| 51.43% | 47.14% | 47.14% | 14.52% | 3.50% | 6.98% | 4.17% | 1.53% | 1.67% | 0.16% | |
| 16.97% | 28.28% | 0.00% | 5.19% | 9.95% | 0.80% | 2.72% | 1.10% | 3.47% | 0.16% | 0.15% |
| 0.901 | | 25.375 | | 31.545 | | 37.799 | | 47.692 | |
| 0.358 | | 4.845 | | 5.040 | | 5.476 | | 1.628 | |
| 39.69% | | 19.09% | | 15.98% | | 14.49% | | 3.41% | |

Readings for QC F that were reported as >200 are shown as blanks, no statistics were possible.

Readings for QC F that were reported as 2200 are showled to belief. In other from CAP survey)

3

Site 3 Precision
Intra Assay
CV %	Day	QC A
Run 1	QC A
Run 2	QC B
Run 1	QC B
Run 2	QC C
Run 1	QC C
Run 2	QC D
Run 1	QC D
Run 2	QC E
Run 1	QC E
Run 2	QC F
Run 1	QC F
Run 2
	1	0.00%	41.59%	47.14%	20.20%	21.49%	14.63%	0.23%	3.13%	5.19%	4.81%		2.42%
	2	31.43%	47.14%	28.28%	35.36%	0.66%	7.99%	1.58%	4.81%	1.27%	1.04%
	3	53.03%	35.36%	41.59%	28.28%	14.59%	0.31%	2.08%	4.89%	2.63%	3.21%
	4	35.36%	41.59%	35.36%	35.36%	11.24%	3.86%	2.59%	0.92%	1.00%	0.79%
	5	30.74%	42.43%	37.22%	31.43%	4.07%	2.85%	8.86%	8.21%	1.78%	0.65%
	6	40.41%	31.43%	8.32%	31.43%	17.65%	5.26%		18.06%	4.93%	0.94%
	7	23.57%		25.71%		3.01%		29.86%		0.00%
	8	35.36%	51.43%	38.57%	47.14%	8.12%	1.38%	9.91%	13.65%	8.35%	4.16%		2.46%
	9	6.15%	28.28%	64.28%	42.43%	12.75%	11.93%	6.04%	7.35%	5.61%	3.23%
	10	42.43%	30.30%	37.22%	42.43%	5.22%	3.46%	4.09%	6.19%	6.36%	0.40%
	11	38.57%	28.28%	53.03%	47.14%	0.00%	2.24%	3.88%	4.74%	1.26%	5.17%
	12	64.28%	30.74%	42.43%	37.22%	4.99%	0.51%	3.84%	1.94%	0.17%	1.05%
	13	24.38%	32.64%	66.99%	33.67%	1.09%	2.89%	3.59%	6.10%	2.58%	1.54%
	14	41.59%	47.14%	31.43%	28.28%	1.86%	8.04%	11.88%	3.61%	7.79%	1.54%
	15	38.57%	40.41%	47.14%	41.59%	0.98%	3.87%	7.34%	8.32%	3.93%	1.13%
	16	37.22%	37.22%	52.10%	47.14%	24.87%	6.56%	7.44%	5.05%	2.56%	5.78%
	17	47.14%	66.00%	22.33%	54.39%	8.13%	15.41%	3.26%	2.28%	0.20%	0.69%
	18	47.14%	37.22%	28.28%	35.36%	0.56%	0.81%	8.15%	11.26%	3.36%	6.09%
	19	30.00%	32.64%	6.15%	33.67%	7.44%	2.89%	14.22%	6.10%	12.41%	1.54%
	20	40.41%	41.59%	0.00%	47.14%	8.94%	1.50%	5.77%	6.51%	2.38%	6.15%	6.59%

Interassay
Mean		1.036		0.877		25.086		32.538		36.863		46.964
Interassay
SD		0.368		0.276		3.970		5.013		4.365		1.527
Interassay
CV%		35.54%		31.45%		15.83%		15.41%		11.84%		3.25%

Note:		Readings for QC F that were reported as >200 are shown as blanks, no statistics were possible.
	When low results are reported on an analyte, a high coefficient of variation (CV) may result. (Taken from CAP survey)

100 Children Children

. . . . . . . .

4

1. Linearity/Reportable range: the strong positive and weak positive samples were diluted seven times at evenly spaced intervals. The R2 of the regression line came out to be 0.974. See data below and the next page.

| Mago 4S Linearity Study

RUBELLA Single Pt	Site - DMX
			Mean	Expected
Name	M4S Conc.	Mean	ordered	Conc.
RUBLOW	0	0.05	0.05	0.05
A-02	0.1		1.15	0.6474
.417L/.083H	1.3	1.15	1.85	1.2948
A-04	1		2.15	1.95
.334L/.166H	2	1.85	2.9	2.6052
A-06	1.7		3.65	3.2526
.25L/.25H	2.1	2.15	3.9	3.9
A-08	2.2
.166L/.334H	2.7	2.9
A-10	3.1
.083L/.417H	3.6	3.65
A-12	3.7
RUBHIGH	4.1	3.9
A-14	3.7

5

Image /page/5/Figure/0 description: The image is a graph titled "Linearity RUBELLA Single Point". The graph shows the relationship between the M4S Value and the Expected Conc. There are several data points plotted on the graph, and a line of best fit is drawn through the points. The equation of the line is y = 1.0017x - 0.2823, and the R-squared value is 0.9741.

1. Positive and Negative Agreement with Comparator and Assessment of Equivocal Zone:
  For Sensitivity and Specificity, approximately 100 samples in,the 20 IU/ml range were assayed. A total of two hundred and eight sera were tested once manually and once on the Mago 4S. The breakdown of Positive, Negative, and Equivocal results are seen in the Table below.

| Mago 4S

Manual	Positive	Negative	*Equivocal	Total
Positive	98	0	2	100
Negative	2	80	3	85
*Equivocal	10	1	12	23
Total	110	81	17	208

Comparison of Oualitative Results of Manual versus Mago 4S
------------------------------------------------------------	--	--	--	--	--	--

Equivocal results are excluded from calculations.

An assessment of Equivocal Zone was subsequently performed, and each kit was tested on the MAGO 4S and manually against the approximately 20 patient samples which were earlier identified in a retest zone (having originally tested manually between 7 and 13 IU/ml). The results showed that there was a single sample mean that indicated positive (≥ 10 IU/ml) on the manual test and indicated 1.25)
(typical results) | Only 2 sera pairs
with bad ratios; 39
sera pairs with
"good ratios;" also,
all 18 results from 9
negative sera pairs
were negative | PASS |
| Correlation of DMX titer
with HI titer of paired sera | No Major Deviations
from continuously.
increasing signals for
sera pairs | No Major Deviations
from continuously
increasing signals
for sera pairs | PASS |

Summary of Evaluation of MAGO 4S Results of CDC Rubella serum panel

1. CDC Biological Standard results: CDC Biological Standard, Low-Titer Anti Rubella Human Reference Serum, was used to verify the Diamedix Rubella IgG assay cutoff. This standard contains 21.0 IU/ml of Rubella IgG antibody. A dilution series was performed starting with a 1:2 dilution. The expected value for the 1:2 dilution of the CDC standard is 10 to 15 IU/ml, which is in agreement with the CDC immunity cutoff reference level. The results were within range as shown on the Table below and on the next page.

7

			Low Titer CDC Control
--	--	--	-----------------------	--

| | OD | IU/ml | Result | Target | Target -
10% | Target
+10% |
|-------------|-------|-------|--------|--------|-----------------|----------------|
| CDC 1:8 | 0.286 | 4.6 | Neg | | | |
| CDC 1:8 Rep | 0.277 | 4.4 | Neg | 3.625 | 3.2625 | 3.9875 |
| CDC 1:4 | 0.424 | 7.3 | Equiv | | | |
| CDC 1:4 Rep | 0.443 | 7.7 | Equiv | 7.25 | 6.525 | 7.975 |
| CDC 1:2 | 0.707 | 14.4 | Pos | | | |
| CDC 1:2 Rep | 0.69 | 13.9 | Pos | 14.05 | 12.645 | 15.455 |
| CDC | 0.951 | 24.8 | | | | |
| CDC Rep | 1.033 | 31.4 | | 28.1 | 25.29 | 30.92 |

Image /page/7/Figure/2 description: The image is a graph titled "CDC Low Titer Dilution Series". The x-axis is labeled "Result IU/ml" and ranges from 0 to 35. The y-axis is labeled "Target" and ranges from 0 to 30. The graph plots a series of data points labeled "Series1" and includes a linear trendline with the equation y = 0.8949x + 0.4145 and an R-squared value of 0.9939.

8

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol features a winding, ribbon-like shape that could be interpreted as a serpent or a staff.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Diamedix Corp. c/o Glenn Gerstenfeld Director of Quality Assurance Regulatory Affairs 2140 N. Miami Avenue Miami, FL 33127

JAN 2 1 - 2011

Re: K093101

Trade/Device Name:	MAGO 4S
Regulation Number:	21 CFR §866.3510
Regulation Name:	Rubella virus serological reagents
Regulatory Class:	Class II
Product Code:	LFX, JJF
Dated:	December 1, 2010
Received:	December 2, 2010

Dear Mr. Gerstenfeld:

We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

9

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Vouy a Hogn

Sally A. Hoivat. M.S. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

10

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K093101 Device Name: Indications for Use:

For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.

The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

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

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

X	Division Sign-Off

Prescription Use (Per 21 CFR 801. subpart D)	Office of In Vitro Diagnostic Device-Counter Use (Per 21 CFR 801. subpart C)
Evaluation and Safety

K093101

510(k)________________________________________________________________________________________________________________________________________________________________________