Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic assay for measuring fructosamine using chemical reagents and a chemistry analyzer. There is no mention of AI or ML in the device description, intended use, performance studies, or key metrics. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
The device is an in vitro diagnostic (IVD) assay designed to measure fructosamine in human serum or plasma to monitor diabetic patients, which is a diagnostic and monitoring function, not a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma... Measurement of fructosamine is representative of blood glucose levels over the preceding 2-3 weeks, and is useful for monitoring diabetic patients." This indicates the device is used to diagnose or monitor a medical condition.

SaMD (Software as a Medical Device)

No

The device is a reagent kit and calibrator for an in vitro diagnostic assay, which are physical components used in a laboratory setting, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma..." and "For in vitro diagnostic use in the calibration of the ADVIA® Chemistry Fructosanine (FRUC) assay...". This is the primary indicator of an IVD.
Measurement of Biomarkers: The device measures fructosamine, a biomarker in human serum or plasma, which is used for monitoring diabetic patients. This is a typical application for IVD devices.
Use with Biological Samples: The device is designed to be used with human serum or plasma, which are biological samples.
Purpose of Diagnosis or Monitoring: The measurement of fructosamine is stated to be "useful for monitoring diabetic patients," which falls under the scope of diagnostic or monitoring purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ADVIA® Chemistry Fructosamine (FRUC) Assay
For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA® Chemistry systems. Measurement of fructosamine is representative of blood glucose levels over the preceding 2-3 weeks, and is useful for monitoring diabetic patients.

ADVIA® Chemistry Fructosamine Calibrator
For in vitro diagnostic use in the calibration of the ADVIA® Chemistry Fructosamine (FRUC) assay on ADVIA Chemistry systems.

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

LCP, JIT

Device Description

The ADVIA® Chemistry Fructosamine reagents are ready-to-use liquid packaged for use on ADVIA® 1650 Chemistry system. The reagents are supplied as 100 tests/wedge, with two (2) wedges in each kit.

Reagent 1 (R1) contains Tris Buffer (0.2 mol/L, pH 8.0), Proteinase-K (≥ 1 kU/mL) 4-. Aminoantipyrine (5 mmol/L) and Stabilizers.
. Reagent 2 (R2) contains Tris Buffer (0.2 mol/L, pH 8.65), Fructosaminase (≥ 0.5 kU/mL), Peroxidase (horseradish) (0.5 kU/mL) N-ethyl-N-sulphohydroxypropyl-mtoluidine (TOOS) ( 10 mmol/L ) and Stabilizers.

The ADVIA® Chemistry Fructosamine Calibrator is a single analyte and single level calibrator. It is lyophilized human serum containing pure fructosamine antigen. There are three (3) vials in each kit. Each vial contains 0.08g. The volume per vial (after reconstitution with deionized water) is 1.0 mL.

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)

The following data represent typical performance for the ADVIA® Chemistry Fructosamine Assay and were collected on ADVIA® 1650.Chemistry system. Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, linearity/assay reportable range, limit of detection, method comparison and analytical specificity. All of the evaluation studies gave acceptable results when compared to the predicate device. These studies support that the ADVIA® Chemistry Fructosamine Assay and ADVIA® Chemistry Fructosamine Calibrator when tested on the ADVIA® 1650 Chemistry system are substantially equivalent to the Diazyme Glycated Serum Protein Assay and Randox Fructosamine Calibrator that are currently marketed.

I. Imprecision
Within-Run and Total Precision were established by assaying three samples.
Sample: Serum Pool, N=80, Mean=39 µmol/L, Total CV=3.5
Sample: Serum Pool, N=80, Mean=70 µmol/L, Total CV=2.9
Sample: Serum Pool, N=80, Mean=126 µmol/L, Total CV=1.7
Sample: Serum Control, N=80, Mean=150 µmol/L, Total CV=1.4
Sample: Serum Pool, N=80, Mean=273 µmol/L, Total CV=1.0
Sample: Serum Control, N=80, Mean=429 µmol/L, Total CV=1.0
Sample: Serum Pool, N=80, Mean=540 µmol/L, Total CV=0.9
Sample: Serum Pool, N=80, Mean=731 µmol/L, Total CV=0.8

II. Linearity/assay reportable range
Linearity was assessed by assaying equally spaced dilutions across the measuring range. The ADVIA® Chemistry Fructosamine Assay on ADVIA® 1650 Chemistry system is linear from 30-1000 µmol/L with a deviation from linearity of 10% bias. Bias exceeding 10% is considered interference.
Interference observed for Bilirubin (conjugated and unconjugated) at higher concentrations, Hemolysis at higher concentrations, and Ascorbic Acid at higher concentration. Other substances showed No Significant Interference (NSI).

VII. Reagent and Calibrator Stability
Reagent: opened products stable for 60 days on system. Shelf life 12 months at 2-8°C.
Calibrator: opened products stable for 28 days when recapped and stored at 2-8°C. Shelf life 12 months at 2-8°C.

VII. Value Assignment
The ADVIA Chemistry FRUC assay is traceable to an internal standard. Value assignment carried out by nested testing protocol.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K042193, K023763

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).

Summary

0

510(k) Summary of Safety and Effectiveness for the ADVIA® Chemistry Fructosamine (FRUC) Assay and Calibrator

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

A. 510(k) Number:

B. Date of Preparation: May 3, 2013

C. Proprietary and Established Names:

ADVIA® Chemistry Fructosamine (FRUC) Assay ADVIA® Chemistry Fructosamine Calibrator

D. Applicant

Contact:	Kira Gordon
	Sr. Regulatory Technical Specialist
Address:	Siemens Healthcare Diagnostics, Inc
	511 Benedict Ave
	Tarrytown, NY 10591
Phone:	(914) 524-2996
	(914) 524-3579 (fax)

E. Regulatory Information:

Reagent

1. Regulation section:
21 CFR §864.7470, Glycosylated hemoglobin assay
1. Classification: Class II
1. Product Code: LCP
1. Panel: Hematology (81)

Calibrator

1. Regulation section: 21 CFR §862.1150, Calibrator, secondary
1. Classification: Class II
1. Product Code: JIT
1. Panel: Clinical Chemistry (75)
F. Predicate Device:

Reagents:

I. Device Name:

1

Diazyme Glycated Serum Protein Assay 2. Common Name:

Diazyme Glycated Serum Protein Assay
1. 510(k) Number: K042193
1. Manufacturer: Diazyme Laboratories

Calibrators:

1. Device Name: Randox Fructosamine Calibrator
1. Common Name: Randox Fructosamine Calibrator
1. 510(k) Number: K023763
1. Manufacturer: Randox Laboratories, Ltd.

G. Intended Use and Indication for Use:

ADVIA Chemistry Fructosamine (FRUC) Assay

For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA® Chemistry systems. Measurement of fructosamine is representative of blood glucose levels over the preceding 2-3 weeks, and is useful for monitoring diabetic patients.

ADVIA Chemistry Fructosamine Calibrator

For in vitro diagnostic use in the calibration of the ADVIA® Chemistry Fructosamine (FRUC) assay on ADVIA Chemistry systems.

H. Device Description:

The ADVIA® Chemistry Fructosamine reagents are ready-to-use liquid packaged for use on ADVIA® 1650 Chemistry system. The reagents are supplied as 100 tests/wedge, with two (2) wedges in each kit.

Reagent 1 (R1) contains Tris Buffer (0.2 mol/L, pH 8.0), Proteinase-K (≥ 1 kU/mL) 4-. Aminoantipyrine (5 mmol/L) and Stabilizers.
. Reagent 2 (R2) contains Tris Buffer (0.2 mol/L, pH 8.65), Fructosaminase (≥ 0.5 kU/mL), Peroxidase (horseradish) (0.5 kU/mL) N-ethyl-N-sulphohydroxypropyl-mtoluidine (TOOS) ( 10 mmol/L ) and Stabilizers.

The ADVIA® Chemistry Fructosamine Calibrator is a single analyte and single level calibrator. It is lyophilized human serum containing pure fructosamine antigen. There are three (3) vials in each kit. Each vial contains 0.08g. The volume per vial (after reconstitution with deionized water) is 1.0 mL.

I. Test Principle:

In the ADVIA® Chemistry Fructosamine Assay, Reagent 1 contains proteinase K, which digests the glycated protein to yield glycated protein fragments. Fructosaminase in Reagent 2

2

oxidizes the ketoamine bond of the glycated protein fragments. As a result hydrogen peroxide is released and it is involved in a colorimetric Trinder end-point reaction. The amount of color developed and measured at 596 nm is proportional to the concentration of glycated protein in the sample.

J. Substantial Equivalence Information:

1. Predicate device name:
- Reagent: Diazyme Glycated Serum Protein Assay;
1. Calibrator: Randox Fructosamine Calibrator Predicate K number:
1. Reagent: K042193 Calibrator: K023763

Comparison with predicate:

Assay:
Similarities and Differences: Assay
ITEM	NEW DEVICE:
ADVIA® Chemistry Fructosamine
(FRUC) Assay	PREDICATE DEVICE:
Diazyme Glycated Serum
Protein Assay
Intended
Use/Indications for
Use	For in vitro diagnostic use in the
quantitative measurement of glycated
protein (fructosamine) in human serum
or plasma on the ADVIA® Chemistry
systems. Measurement of fructosamine
is representative of blood glucose levels
over the preceding 2-3 weeks, and is
useful for monitoring diabetic patients.	Same (for the quantitative
determination of glycated
serum proteins (GSP;
glycated albumin;
fructosamine): The
measurement of glycated
serum proteins is useful for
monitoring diabetic patients.
Instrument used	ADVIA® 1650 Chemistry system	Clinical Chemistry analyzer
Measurement	Quantitative	Same
Specimen types	Human Serum and plasma (Lithium
heparin, potassium EDTA)	Serum
Reference range	122-236 µmol/L	Same
Format	Liquid	Same
Analytical Range	30-1000 µmol/L	21-1354 µmol/L
Assay Principle/
Methodology	Enzymatic reaction	Same

Calibrator:

Similarities and Differences: Calibrator
Item	NEW DEVICE:
ADVIA® Chemistry Fructosamine
Calibrator	PREDICATE DEVICE:
Randox Fructosamine
Calibrator
Intended Use	For in vitro diagnostic use in the
calibration of the ADVIA® Chemistry	Same-
Intended for in vitro use in

Page 3 of 7

3

| | Fructosamine (FRUC) assay on
ADVIA® Chemistry systems. | the calibration of
Fructosamine on clinical
chemistry systems. |
|----------------|-----------------------------------------------------------|----------------------------------------------------------------------|
| Form | Lyophilized | Same |
| Analyte source | Derived from human source | Same |
| Levels | Single | Same |
| Fill Volume | 0.08g→1.0mL reconstituted | Same |
| Storage | 2–8°C | Same |

K. Standard/Guidance Document Reference

a. Interference Testing in Clinical Chemistry; Approved Guideline Second Edition(CLSI EP7-A2)
b. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition (CLSI EP17-A2)
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved C. Guideline-Second Edition (CLSI EP5-A2)

L. Performance Characteristics

The following data represent typical performance for the ADVIA® Chemistry Fructosamine Assay and were collected on ADVIA® 1650.Chemistry system. Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, linearity/assay reportable range, limit of detection, method comparison and analytical specificity. All of the evaluation studies gave acceptable results when compared to the predicate device. These studies support that the ADVIA® Chemistry Fructosamine Assay and ADVIA® Chemistry Fructosamine Calibrator when tested on the ADVIA® 1650 Chemistry system are substantially equivalent to the Diazyme Glycated Serum Protein Assay and Randox Fructosamine Calibrator that are currently marketed.

I. Imprecision

Within-Run and Total Precision were established by assaying three samples. Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days. Precision estimates were computed according to CLSI document EP5-A2, Evaluation of Precision Performance of Ouantitative Measurement Methods: Approved Guideline

| Sample | N | Mean
(µmol/L) | Within Run | | Between Run | | Between Day | | Total | |
|---------------|----|------------------|------------|-----|-------------|-----|-------------|-----|-------|-----|
| | | | SD | CV | SD | CV | SD | CV | SD | CV |
| Serum Pool | 80 | 39 | 1.1 | 2.8 | 0.8 | 1.9 | 0 | 0 | 1.4 | 3.5 |
| Serum Pool | 80 | 70 | 0.5 | 0.7 | 1.2 | 1.7 | 1.6 | 2.2 | 2.0 | 2.9 |
| Serum Pool | 80 | 126 | 0.7 | 0.5 | 1.5 | 1.2 | 1.4 | 1.1 | 2.2 | 1.7 |
| Serum Control | 80 | 150 | 0.5 | 0.3 | 1.1 | 0.7 | 1.8 | 1.2 | 2.2 | 1.4 |
| Serum Pool | 80 | 273 | 0.9 | 0.3 | 1.9 | 0.7 | 1.6 | 0.6 | 2.6 | 1.0 |
| Serum Control | 80 | 429 | 1.1 | 0.3 | 2.2 | 0.5 | 3.5 | 0.8 | 4.2 | 1.0 |
| Serum Pool | 80 | 540 | 1.3 | 0.2 | 3.2 | 0.6 | 3.3 | 0.6 | 4.7 | 0.9 |
| Serum Pool | 80 | 731 | 1.9 | 0.3 | 1.9 | 0.3 | 5.2 | 0.7 | 5.8 | 0.8 |

II. Linearity/assay reportable range

Linearity was assessed by assaying equally spaced dilutions across the measuring range. The low end of the assay range is calculated based on the Limit of Quantitation. The high

4

end of the assay range is based on the linearity calculation. The ADVIA® Chemistry Fructosamine Assay on ADVIA® 1650 Chemistry system is linear from 30-1000 µmol/L with a deviation from linearity of 10% bias. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference.

| Interferent | Interferent Level | Fructosamine Sample
Concentration | Interference* |
|-----------------------------------------------|--------------------------|--------------------------------------|---------------|
| Bilirubin
(conjugated) | 5 mg/dL (86 µmol/L) | 165 µmol/L | NSI |
| | 10 mg/dL (171 µmol/L) | 165 µmol/L | -18.3% |
| | 5 mg/dL (86 µmol/L) | 263 µmol/L | NSI |
| | 10 mg/dL (171 µmol/L) | 263 µmol/L | -13.6% |
| Bilirubin
(unconjugated) | 5 mg/dL (86 µmol/L) | 165 µmol/L | NSI |
| | 10 mg/dL (171 µmol/L) | 165 µmol/L | -16.2% |
| | 10 mg/dL (171 µmol/L) | 264 µmol/L | NSI |
| | 15 mg/dL (257 µmol/L) | 264 µmol/L | -12.4% |
| Hemolysis | 250 mg/dL (2.5 g/L) | 154 µmol/L | NSI |
| | 500 mg/dL (5.0 g/L) | 154 µmol/L | -11.3% |
| | 750 mg/dL (7.5 g/L) | 253 µmol/L | NSI |
| | 1000 mg/dL (10.0 g/L) | 253 µmol/L | -13.7% |
| Lipemia
(from Triglyceride
Concentrate) | 1000 mg/dL (11.3 mmol/L) | 156 µmol/L | NSI |
| | 1000 mg/dL (11.3 mmol/L) | 256 µmol/L | NSI |
| Ascorbic Acid | 10 mg/dL (568 µmol/L) | 156 µmol/L | NSI |
| | 15 mg/dL (852 µmol/L) | 156 µmol/L | +13.2% |
| | 20 mg/dL (1136 µmol/L) | 250 µmol/L | NSI |
| Glucose | 2800 mg/dL (155 mmol/L) | 154 µmol/L | NSI |
| | 2800 mg/dL (155 mmol/L) | 251 µmol/L | NSI |
| Uric Acid | 50 mg/dL (2975 µmol/L) | 158 µmol/L | NSI |
| | 50 mg/dL (2975 µmol/L) | 251 µmol/L | NSI |
| Albumin | 6.1 g/dL (61 g/L) | 132 µmol/L | NSI |
| Total Protein | 8.4 g/dL (84 g/L) | 489 µmol/L | NSI |

6

VII. Reagent and Calibrator Stability

Reagent: for opened products, once placed on the system reagents are stable for 60 days. The shelf life of the ADVIA Chemistry Fructosamine Reagent is 12 months at 2-8℃. For unopened product, see the expiration date on the reagent carton.

Calibrator: for opened products, once the cap is removed, assigned values are stable for 28 days when recapped immediately after use and stored at 2-8℃. The shelf life of the ADVIA Chemistry Fructosamine Calibrator is 12 months at 2-8℃. For unopened product, see the expiration date on the calibrator carton.

VII. Value Assignment

The ADVIA Chemistry FRUC assay is traceable to an internal standard. Assigned values of the ADVIA Chemistry Fructosamine Calibrator are traceable to this standardization. The value assignment is carried out by a nested testing protocol using one lot of reagent on one ADVIA® 1650 Chemistry system with ten (10) replicates of the Master Lot and Test Lot calibrators in the same worklist. The Test Lot values are adjusted with a ratio derived from the Master Lot Calibrator assigned value (Target value) and the mean recovery of the Master Lot Calibrator values (observed) according to the following equation: Test Lot assigned value = (Master Calibrator Target value / Mean Recovery of the Master Lot Calibrator observed) * Mean Recovery of Test Lot observed.

VII. Clinical Studies

Not applicable.

VIII. Clinical cut-off

Not applicable.

M. Conclusion

The ADVIA® Chemistry Fructosamine Assay on ADVIA® 1650 Chemistry system is substantially equivalent in principle and in performance to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Diazyme Glycated Serum Protein Assay (K042193).

The ADVIA® Chemistry Fructosamine Calibrator on ADVIA® 1650 Chemistry system is substantially equivalent n principle and in performance to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Randox Fructosamine Calibrator (K023763).

7

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/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" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2014

SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON SR. REGULATORY TECHNICAL SPECIALIST 511 BENEDICT AVE TARRYTOWN NY 10591

Re: K131307

Trade/Device Name: ADVIA® Chemistry Fructosamine (FRUC) Assay ADVIA® Chemistry Fructosamine Calibrator Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JIT Dated: December 6, 2013 Received: December 9, 2013

Dear Dr. Gordon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Parts 801 and 809); 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.

8

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/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,

CourtneyH.Lias-S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

9

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K131307

Device Name

ADVIA® Chemistry Fructosamine (FRUC) Assay; ADVIA® Chemistry Fructosamine Calibrator

Indications for Use (Describe) The ADVIA® Chemistry Fructosamine (FRUC) Assay

For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA® Chemistry systems. Measurement of fructosamine is representative of blood glucose levels over the preceding 2-3 weeks, and is useful for monitoring diabetic patients.

ADVIA® Chemistry Fructosamine Calibrator

For in vitro diagnostic use in the calibration of the ADVIA® Chemistry Fructosanine (FRUC) assay on ADVIA® Chemistry systems.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE WE WELL FOR FOR FOR FOR FOR FOR FOR THE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

10

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