The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only.

Device Description

Fructosamine is formed due to a non-enzymatic Maillard reaction between glucose and amino acid residues of serum proteins. It is reported in medical literature that 80% of measured glycated serum proteins are glycated albumins. In diabetic patients, elevated blood glucose levels correlate with increased fructosamine formation. Glycated serum proteins (GSP; fructosamine) are a medium term indicator of diabetic control (2-3 weeks).

The Diazyme Glycated Serum Protein POC Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosamiase™, a microorganisms originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield peptide fragments (PF) or amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546 nm is proportional to the concentration of glycated serum proteins. The SMART analyzer calculates the GSP concentrations of patient serum specimens by use of a lot specific calibration curve. The lot specific curve is represented in a Calibration card (RFID) provided with each GSP POC Test Kit.

SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 40ul of sample to the DRS cuvette prefilled with R1 containing proper buffer. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 546nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and lot specific calibration curve.

The Diazyme GSP POC Test Kit system thus consists of the following:

. GSP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.

AI/ML Overview

The provided document describes the Diazyme Glycated Serum Protein POC Test Kit and its performance characteristics. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for precision or linearity. However, it presents the performance data in a way that implies these are the achieved results for demonstrating substantial equivalence. The predicate device's performance is listed, and the new device's performance is compared for similarity.

Performance Metric	Acceptance Criteria (Implied from Predicate/Good Practice)	Reported Device Performance (Diazyme GSP POC Test Kit)
Linearity	Similar to predicate (up to 1354 µmol/L)	61 to 1348 µmol/L (Linear from 2 to 1348 µmol/L tested)
Precision (Within %CV)	Less than 2.0% CV (predicate)	≤ 6.1% CV (Serum Level 1) ≤ 1.5% CV (Serum Level 5)
Precision (Total %CV)	Less than 2.0% CV (predicate)	≤ 5.6% CV (Serum Level 1) ≤ 1.8% CV (Serum Level 5)
Accuracy (Correlation Coefficient)	Similar to predicate (0.9966)	0.9975
Accuracy (Slope)	Similar to predicate (0.9542)	0.9737
Accuracy (Intercept)	Similar to predicate (14.57 µmol/L)	0.6859 µmol/L

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

Test Set Sample Size for Comparison Study: 54 serum specimens
Test Set Sample Size for Precision Study: 5 serum samples, each tested 80 times (2 runs/day, duplicates, over 20 working days). This implies a total of 400 individual measurements (5 samples * 80 measurements/sample).
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective for the device's performance characterization, as it describes actively testing samples with the new device and comparing them to results from the predicate.

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

Not applicable. This device is an in-vitro diagnostic assay that measures a biomarker. The "ground truth" for the test set is established by the well-characterized predicate device (Diazyme Glycated Serum Protein Assay on Hitachi 917 analyzer). No human experts are used to establish a subjective "ground truth" for a diagnostic image or interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative measurement against a predicate, there is no expert adjudication process. The comparison is statistical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a point-of-care in-vitro diagnostic test, not an imaging device or AI-assisted diagnostic tool that involves human reader interpretation. Therefore, an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (Linearity, Precision, Interference, and Comparison Studies) are all for the Diazyme GSP POC Test Kit operating in a standalone capacity, measuring GSP levels in serum samples without human intervention in the result generation itself (beyond sample loading). The SMART Analyzer with its RFID card is essentially the "algorithm" that interprets the optical readings and calculates the GSP concentration.

7. The Type of Ground Truth Used

The ground truth used for the comparison study is the measurement result from the legally marketed predicate device (Diazyme Glycated Serum Protein Assay on Hitachi 917 analyzer (K110188)). For the linearity, precision, and interference studies, the "ground truth" is based on the known concentrations of the prepared samples or spiked substances.

8. The Sample Size for the Training Set

Not applicable. This device is an analytical instrument and reagent kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical detection. The RFID card contains a "lot specific calibration curve," which is developed by the manufacturer. While this involves data, it's not a "training set" for an AI model.

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

Not applicable. See point 8. The "calibration curve" stored on the RFID card is established through a calibration process using known standards (calibrators) to ensure accurate measurements across the reportable range. This is a standard procedure for IVD assays.

Summary

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

DIAZYME LABORATORIES DR. ABHIJIT DATTA 12889 GREGG COURT POWAY CA 92064

August 6, 2014

Re: K133803

Trade/Device Name: Diazyme Glycated Serum Protein POC Test Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP Dated: July 9, 2014 Received: July 10, 2014

Dear Dr. Datta:

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.

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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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : 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

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Indications for Use

510(k) Number (if known) K133803

Device Name Diazyme Glycated Serum Protein POC Test Kit

Indications for Use (Describe)

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

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.

FOR FDA USE ONLY

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

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510(k) SUMMARY & SUBSTANTIAL EQUIVALENCE COMPARISON

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

Submitter's name:	Diazyme Laboratories
Submitter's address:	12889 Gregg CourtPoway, CA 92064USA
Name of Contact Person:	Dr. Abhijit DattaDiazyme Laboratories12889 Gregg CourtPoway, CA 92064Phone: 858-455-4762Fax: 858-455-2120abhijit.datta@diazyme.com
Date the Summary was Prepared	July 9, 2014
Name of Device	Diazyme Glycated Serum Protein POC Test Kit
Trade Name	Diazyme GSP POC Test Kit
Common/Usual Name	Diazyme GSP POC Test Kit
Device Classification Name	Assay, Glycosylated Hemoglobin
Product Code	LCP
Panel	Clinical Chemistry
Submission Type	Traditional 510k
Regulation Number	864.7470 - Glycosylated hemoglobin assay
Device Class	Class II

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Predicate Device	Diazyme Glycated Serum Protein (GSP) Assay(K110188)Diazyme Glycated Serum Protein Calibrator Kit(K110188)Diazyme Glycated Serum Protein Control Kit(K110188)
Manufacturing Address	Diazyme Laboratories12889 Gregg CourtPoway, CA 92121USA
Establishment Registration	2032900

Executive Summary

Detailed performance characteristics and comparison analysis are given in this filing that demonstrates substantial equivalence of the GSP POC Assay Kit to predicate device that is currently being marketed. The performance characteristics of the GSP POC Assay Kit are substantially similar to that of the approved predicate device (K110188). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the GSP POC Assay and offers POL users an in vitro diagnostic device system to measure GSP in human serum samples.

Device Description:

Clinical Significance

Assay Principle

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The Diazyme GSP POC Test Kit system thus consists of the following:

. GSP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.

Indications for Use

Predicate K110188	Candidate device	Equivalency
Diazyme Glycated Serum ProteinAssay Kit in conjunction with DiazymeGlycated Serum Protein singlecalibrator, are intended for thequantitative determination of glycatedserum proteins (GSP; glycatedalbumins; fructosamine) in serum. Themeasurement of glycated serumproteins is useful for monitoringdiabetic patients	The Diazyme Glycated Serum ProteinPOC Test Kit is intended for thequantitative determination of glycatedserum proteins (GSP; fructosamine) inserum. Fructosamine is representativeof blood glucose levels over the courseof 2-3 weeks. The measurement ofglycated serum proteins is useful formonitoring diabetic patients. For invitro diagnostic use only.	Similar

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Predicate K110188	Candidate device	Equivalency
The Diazyme Glycated Serum ProteinAssay uses Proteinase K to digest Gly-cated Serum Proteins (GSP) into lowmolecular weight glycated proteinfragments (GPF), and uses Diazyme'sspecific fructosaminaseTM, a microor-ganism originated amadoriase to cata-lyze the oxidative degradation ofAmadori product GPF to yield PF oramino acids, glucosone and H2O2. TheH2O2 released is measured by a color-imetric Trinder end-point reaction. Theabsorbance at 600 nm is proportional tothe concentration of glycated serumproteins.	The Diazyme Glycated Serum ProteinPOC Assay uses proteinase K to digestGSP into low molecular weight gly-cated protein fragments (GPF), and us-es Diazyme's specific fructosami-aseTM, a microorganisms originatedamadoriase to catalyze the oxidativedegradation of Amadori product GPF toyield peptide fragments (PF) or aminoacids, glucosone and H2O2. The H2O2released is measured by a colorimetricTrinder end-point reaction. The absorb-ance at 546 nm is proportional to theconcentration of glycated serum pro-teins. The SMART analyzer calculatesthe GSP concentrations of patient se-rum specimens by use of a lot specificcalibration curve. The lot specific curveis represented in a Calibration card(RFID) provided with each GSP POCTest Kit.	Similar

Principle

Test Objective

Predicate K110188	Candidate device	Equivalency
For the in vitro quantitative determina-tion of glycated serum proteins (GSP;glycated albumins; fructosamine) inhuman serum.	For the in vitro quantitative deter-mination of glycated serum proteins(GSP; glycated albumins; fructosamine)in human serum.	Same

Type of Test

Predicate K110188	Candidate device	Equivalency
Quantitative	Quantitative	Same

Methodology

Predicate K110188	Candidate device	Equivalency
Enzymatic method	Enzymatic method	Same

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Specimen

Predicate K110188	Candidate device	Equivalency
Human serum	Human serum	Same

Product Type

Predicate K110188	Candidate device	Equivalency
2 Reagents Liquid (ready-to-use)	Prefilled ready to use DRS Cuvettes, lotspecific RFID calibration card	Similar

Performance

Predicate K110188	Candidate device
Linear Range: up to 1354 µmol/L	Linear Range: 61 to 1348 µmol/L
Precision:
Within: < 2.0 % CV	Within precision ≤ 5.6 % CV
Total: < 2.0 % CV	Total Precision: ≤ 6.1 % CV
Method comparison with predicate:	Accuracy:
Correlation Coefficient: 0.9966	Correlation Coefficient: 0.99
Slope/Intercept: 0.9542/14.57	Slope/Intercept: y = 0.97/ 0.69

Calibrator Comparison

Calibrator Comparison
Predicate K110188	Candidate device	Equivalency
Separately packaged calibrator kit. Usersteps needed to use calibrators.	Each kit has individual lot specificRFID preprogrammed calibration card.User steps limited to insertion inSMART analyzer.	Similar
The instrument calculates the GSPconcentration of a patient specimen byinterpolation of the obtained signal on a2 point calibration curve	The instrument calculates the GSPconcentration of a patient specimen byuse of a lot specific calibration curvethat is stored in an RFID card providedwith each GSP POC kit.

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Control Comparison

Control material is the same as predicate device K110188

Summary of Assay Kit Components
Predicate K110188	Candidate device
Kit can be used on automated chemistry analyzers using validated parameters	Kit can ONLY be used with SMART analyzers
Reagent 11 bottleEnzyme/substrate reagent containing Good's Buffer, 4-AA, enzymes, and stabilizers	Reagent 140 DRS cuvette (prefilled) with reagent R1Enzyme/substrate reagent containing Tris.HCl buffer, 4-AA, Enzymes and stabilizers
Reagent 21 bottleEnzyme/substrate reagent containing Good's Buffer, enzymes, TOOS, HRP, Geneticin, and stabilizers	Reagent 240 DRS caps (prefilled)Enzyme/substrate reagent containing Tris.HCl buffer, enzymes, TOOS, HRP, Geneticin, and stabilizers
Calibrator set2 x 1.0 mL Calibrator 1 and 2	Calibrator1 x preprogrammed lot specific RFID card in each kit
Control Set	Control Set (same as predicate K110188)
1 x 1.0 mL Control 1(buffer based liquid, ready to use)	1 x 1.0 mL Control 1(buffer based liquid, ready to use)
1 x 1.0 mL Control 2(buffer based liquid, ready to use)	1 x 1.0 mL Control 2 (buffer based liquid, ready to use)

Summary of Assay Kit Components

Equipment needed for Diazyme GSP POC Test Kit:

SMART Analyzer (K092911). .
Special conditions for use statement(s):
For prescription use only .
Special instrument requirements:
. For use on SMART Analyzer only

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Performance Characteristics:

Precision Study

The precision of the Diazyme GSP Assay was evaluated according to CLSI EP5-A guideline. In the study, 5 serum samples containing about 87, 226, 479, 743, and 1243 umol/L fructosamine, respectively, were tested 2 runs per day in duplicates over 20 working days.

The mean value (Mean), standard deviation, within-run imprecision and total imprecision are calculated and summarized in the following tables:

Specimen	n	Mean(mg/L)	WithinRun SD(mg/L)	WithinRun CV(%)	Total SD(mg/L)	Total CV(%)
Serum Level 1	80	87	5.26	6.1%	4.8	5.6%
Serum Level 2	80	226	9.75	4.3%	10.14	4.5%
Serum Level 3	80	479	16.10	3.4%	16.48	3.4%
Serum Level 4	80	743	12.12	1.6%	18.81	2.5%
Serum Level 5	80	1243	18.60	1.5%	22.71	1.8%

LOB/LOD/LOQ

LOB = 12 umol/L; The LOD = 30 umol/L and LOQ = 61 umol/L

Linearity/assay reportable range:

Twelve levels of linearity set were prepared by diluting a sample containing 1348 umoVL Fructosamine with low sample with 2 umol/L Fructosamine according to CLSI EP6-A and analyzed on SMART Analyzer. Results indicated linearity from 2 to 1348 umol/L. Allowable systematic error (SEA) was 4.9%.

Interference:

The common interfering substances had no significant interference up to the concentrations summarized below.

Interference	Concentration
Ascorbic Acid	20 mg/dL
Bilirubin	7.5 mg/dL
Bilirubin Conjugated	5 mg/dL
Triglyceride	1000 mg/dL
Glucose	2400 mg/dL
Uric Acid	35 mg/dL

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Hemoglobin	100 mg/dL
Total Protein	12 mg/dL

Comparison studies:

A total of forty nine serum specimens were tested with Diazyme GSP POC Test on SMART analyzer. The correspondent plasma samples were tested with Diazyme GSP Assay on Hitachi 917 analyzer (predicate K110188).

The regression results are summarized in the following table:

	Results
n	54
Slope	0.9737 (95%CI:0.95599-0.9944)
Intercept (µmol/L)	0.6859 (95% CI: -4.7287-7.8918)
Correlation coefficient, r	0.9975 (95%CI:0.9956-0.9985)
Range of values (µmol/L)	70.0 to 1269

Expected value/Reference range

Previously established for predicate device (K110188)

Adults (>18 years) have a reported normal range of 191-289 umol/L. It is recommended that each laboratory establish its own reference range to reflect the age, sex, diet and geographical location of the population.

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).