Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (fructosamine) in serum. The measurement of glycated serum proteins (fructosamine) is useful for monitoring diabetic patients.

Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples.

Diazyme Glycated Serum Protein Enzymatic Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay.

Device Description

Diazyme's glycated serum protein (Dia-GSPTM) assay is a specific enzymatic method for direct determination of fructosamine in serum. The assay utilizes Diazyme's proprietary frucosyl amine-oxygen oxidoreductase (fructosaminase™) to specifically react with the glycated amino acid substrates generated by on-line digestion of serum sample proteins with Proteinases. Liberation of hydrogen peroxide from the fructosaminase™ reaction allows a colorimeter determination of the amount of glycated protein through a coupled reaction with peroxidase.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Diazyme Glycated Serum Protein Enzymatic Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. However, based on the performance characteristics reported and the conclusion of the 510(k) submission, we can infer the implied acceptance criteria were sufficient for demonstrating substantial equivalence. The predicate device is the Randox Fructosamine assay.

Performance Characteristic	Stated Performance (Diazyme Assay)	Implied Acceptance Criteria (Based on Substantial Equivalence to Randox)
Precision		Good precision, comparable to or better than predicate.
Inter-assay Precision	CV% = 1.74 (280 µmol/L)
	CV% = 1.75 (586 µmol/L)
Total Precision	CV% = 2.87 (280 µmol/L)
	CV% = 2.94 (586 µmol/L)
Correlation with Predicate	Correlation coefficient = 0.98	Strong positive correlation (e.g., > 0.95 or similar to predicate).
Interference	Little interference at indicated concentrations for: Uric Acid (2 mM), Hemoglobin (200 mg/dl), Glucose (133 mM), Triglyceride (2000 mg/dl), Ascorbic Acid (0.230 mM), Bilirubin (20 mg/dl)	Minimal or no significant interference by common substances at clinically relevant concentrations.
Measuring Range	0 to 1354 µmol/L	Wide enough for clinical utility and comparable to predicate.

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

Sample Size: The document mentions "clinical patient serum samples" for the correlation study but does not specify an exact number for the test set used to establish the correlation coefficient of 0.98.
Data Provenance: The document does not explicitly state the country of origin. The fact that the submitter is "Diazyme Laboratories Division, General Atomics" in "San Diego, CA 92121" suggests the testing was likely conducted in the US. The study is retrospective, as it involves testing "clinical patient serum samples" rather than following patients prospectively.

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

This information is not provided in the document. The study uses a comparative method against a predicate device (Randox Fructosamine assay), where the predicate assay provides the comparative "truth" for the correlation study, not expert consensus on individual patient samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this type of analytical assay validation. The assessment is based on the quantitative results from the Diazyme assay compared to the quantitative results from the predicate Randox assay, not on qualitative interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This device is an enzymatic assay for measuring levels of a biomarker (glycated serum protein), not an imaging or diagnostic AI device that involves human readers or interpretation of images. Therefore, an MRMC study and AI assistance are not relevant here.

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

This information is not applicable. The device is a laboratory assay kit, not an algorithm. Its performance is inherent to the chemical reactions and spectrophotometric measurements it performs. The "standalone" performance is simply the analytical performance of the assay itself, as demonstrated by the precision, linearity, and interference studies.

7. The Type of Ground Truth Used

The "ground truth" for the comparative effectiveness study (correlation) was established by the results obtained from the legally marketed predicate device, Randox Fructosamine assay (K023763). This is a form of comparative analytical performance. For precision and interference studies, the ground truth is based on known concentrations of analytes and interferents in control samples.

8. The Sample Size for the Training Set

This information is not provided. As an enzymatic assay, there isn't a "training set" in the sense of machine learning. The "training" for such an assay comes from its chemical formulation, optimization of reaction conditions, and calibration procedures.

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

This information is not applicable/provided in the machine learning context. For an enzymatic assay, the "ground truth" for developing and optimizing the assay (analogous to training) would involve:

Careful preparation of standards with known concentrations of glycated serum protein.
Validation of the enzymatic reactions and detection methods using pure compounds and well-characterized biological samples.
Optimization of reagent concentrations, reaction times, and temperature.
This developmental process is inherent to creating any in vitro diagnostic assay.

Summary

{0}------------------------------------------------

Premarket Notification - Diazyme Laboratories

Diazyme Laboratories Division, General Atomics

Image /page/0/Picture/1 description: The image shows the word "DIAZYME" in bold, block letters. Above the word is a four-pointed star-like symbol. The symbol is composed of four diamond shapes arranged around a central point.

Submitter's name:

OCT 2 9 2004

K042193

Summary

Submitter's address:	3550 General Atomics CourtSan Diego, CA 92121
Phone:	858-455-4761
Fax:	858-455-4750
Name of Contact Person:	Chong Yuan, Ph.D.Diazyme Laboratories DivisionGeneral Atomics3550 General Atomics CourtSan Diego, CA 92121Phone: 858-455-4761Fax: 858-455-4750
Date the summary was prepared:	July 7, 2004
Name of the device:	Glycated Serum Protein Enzymatic Assay
Trade Name:	Diazyme Glycated Serum Protein Enzymatic Assay
Common/Usual Name:	Enzymatic Assay, Fructosamine
Classification Name:	Glycosylated Hemoglobin Assay (Per 21CFR section 862.3560)

Predicate Device:

Device Class:

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Randox Fructosamine (K023763) manufactured by Randox Laboratories, Ltd., Antrim, UK.

Description of the devices

Existing methods for the assay of glycated serum proteins or fructosamine such as furosine (HPLC), affinity chromatography, thiobarbituric acid (TBA) and nitroblue tetrazolium (NBT) are time consuming, difficult to automate and/or lack of specificity. Enzymatic assay of fructosamine is proven to be not only more specific and more accurate but also more user friendly for use in automated analyzers.

{1}------------------------------------------------

Intended Use of the Device:

Performance Characteristics

Diazyme's Glycated Serum Protein enzymatic assay is a two reagent (R1 and R2) based end point assay system. The results are obtained in 10 min by measuring absorbance at 550 mm. No off line pretreatment is needed. The assay has a wide measuring range from 0 to 1354 umo//L. The assay offers excellent precision as shown in the table below:

	280 µmol/L	586 µmol/L
Inter-assay Precision	CV%=1.74	CV%=1.75
Total Precision	CV%=2.87	CV%=2.94

Diazyme's Glycated Serum Protein Enzymatic assay has good correlation with Randox Fructosamine assay (correlation coefficient of 0.98). We have conducted interference study by spiking the substances to be tested to the pooled human sera and found little interference at the indicated concentrations

Interference	Concentration
Uric Acid	2 mM
Haemoglobin	200 mg/dl
Glucose	133 mM
Triglyceride	2000 mg/dl
Ascorbic Acid	0.230 mM
Bilirubin	20 mg/dl

Conclusion: Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's Glycated Serum Protein Enzymatic assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Glycated Serum Protein Enzymatic assay and legally marketed predicate Randox Fructosamine when testing clinical patient serum samples. Therefore, Diazyme's Glycated Serum Protein Enzymatic assay is substantially similar to the commercially available products to measure glycated serum proteins in human serum samples.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with their arms raised.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 9 2004

Chong Yuan, Ph.D. Managing Director Diazyme Laboratories Div. of General Atomics 3550 General Atomics Ct. San Diego. CA 92121

Re: K042193

Trade/Device Name: Diazyme Glycated Serum Protein Enzymatic Assay Kit Diazyme Glycated Serum Controls Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JJX Dated: July 14, 2004 Received: August 12, 2004

Dear Dr. Yuan:

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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, U.S. D.V.M.

Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

K042193 510(k) Number (if known):

Device Name: Diazyme Glycated Serum Protein Enzymatic Assay Kit

Indications for Use:

Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and

510(k) K0421.93

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).