(216 days)
No
The device description focuses on enzymatic assay principles, spectrophotometry, and RFID card usage for calibration and parameters. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
The device is for in vitro diagnostic use only, providing quantitative determination of HbA1c, which is an indicator for diabetic control, but it does not directly treat or prevent a disease.
Yes
The device is intended for the quantitative determination of stable HbA1c in human blood samples, which is a valuable indicator for long-term diabetic control, thus serving a diagnostic purpose for diabetes management.
No
The device description clearly outlines a system that includes hardware components: a compact cuvette based spectrophotometer machine (SMART analyzer), reagent kits, and control kits. While software is likely involved in the analyzer's operation and data processing, the system is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only." This is repeated for the reagent kit, controls, and the entire system.
- Definition of IVD: An in vitro diagnostic product is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device analyzes human whole blood samples to determine HbA1c levels, which is a key indicator for diabetic control.
- Components: The system includes reagents, controls, and an analyzer, all designed to perform a diagnostic test on a biological sample outside of the body.
The provided text strongly indicates that this device is intended and designed for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
SMART Hemoglobin A1c (Glycated hemoglobin A1c; A1c; HbA1c) reagents are intended for use with the SMART analyzer for the quantitative determination of stable HbA1c in human capillary and venous whole blood samples. Measurement of hemoglobin A 1c is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only.
SMART HbA1c Assay Controls are intended for use as quality controls for the SMART HbA1c Assay reagents. For in vitro diagnostic use only.
SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care use, designed to analyze readings from single use SMART reagent cuvette. The SMART Analyzer System, consisting of the SMART Analyzer, SMART HbA1c reagent kit and SMART HbA1c Assay Controls, is for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJX, JJE
Device Description
SMART HbAlc Assay Kit contains reagents intended for use with the SMART HbA1c analyzer for the quantitative determination of stable HbA1c in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. SMART HbA1c assay reagents are similar to the predicate Direct Enzymatic HbA1c assay reagents (K070734). The similarities and differences in composition and format are noted in Table 1 below. The SMART HbA1c test is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion with Bacillus sp protease. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as substrates for specific recombinant fructosyl valine oxidase (FVO) enzyme, produced in E. coli. The recombinant FVO specifically cleaves N-terminal valines and produces hydrogen peroxide. This, in turn, is measured using a horseradish peroxidase (POD) catalyzed reaction and a suitable chromagen. The HbA1c concentration is expressed directly as %HbA1c by use of a lot specific calibration curve that is stored in an RFID card provided with each SMART test kit. The manufacturer of the SMART HbA1c Assay kit is Diazyme Laboratories.
SMART HbA1c Assay Control Kit is intended for use as quality controls for the SMART HbAlc Assay Reagents and is packaged separately. The OC materials were pre market cleared with predicate device (K070734, K050178) and each lot of SMART HbA1c control kits will be tested with the SMART system during value assignment. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If QC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists. The manufacturer of the SMART HbA1c Assay Control kit is Diazyme Laboratories.
SMART HbA1c analyzer 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 cuvettes. The instrument only uses the Diazyme Reagent System (DRS) cuvettes and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with R1a and the DRS cap is supplied prefilled with R2. The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to prepare hemolysate samples in micro tubes prefilled with Lysis buffer and prepare R1ab mix by transferring R1b from supplied bottle to cuvette. Users are then instructed to transfer hemolysate to cuvette, snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37C and after a predefined period adds the second reagent found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700mm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The SMART analyzers are manufactured for Diazyme Laboratories by Eurolyser Diagnostica, GMBH (Eurolyser Diagnostica GmbH, Bayernstraße 11a, 5020 Salzburg, AUSTRIA; www.eurolyser.com; Fon: +43 662 432100; Fax: +43 662 432100 50). Eurolyser Diagnostica, GMBH establishment registration number is 3006490192. Eurolyser Diagnostica developed and commercialized the SMART analyzers in Europe with their contract manufacturing partner AKATech, GMBH (AKAtech Produktions- und Handels GmbH, Untermühlberg 1, 4890 Frankenmarkt, AUSTRIA;
http://www.akatech.at/en/index.php?option=com_content&task=view&id=31&I.: +43 (7684) 88 04-0; Fax: +43 (7684) 88 04-9). AKATech is ISO13485 and ISO 9001 quality system certified.
The SMART HbA1c Analyzer System thus consists of the following:
-
- SMART HbAlc Assay Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART HbAlc analyzer.
-
- SMART HbA1c Assay Control Kit. Controls are provided for quality control of the SMART Hba1c assay
-
- SMART Analyzer. SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care testing, designed to analyze readings from single use SMART reagent cuvettes.
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
point-of-care testing
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)
Precision Study Summary: The precision of the SMART HbA1c Assay was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline. Two unaltered whole blood specimens containing 5.6% and 7.4% HbA1c, and one whole blood based HbAlc control containing 11.5% HbA1c were tested with 2 runs per day with duplicates over 10 working days. Reagent Lot 1 was used over the first 5 days and Reagent Lot 2 was used over the remaining 5 days. Both lots of reagents were used on three different SMART HbA1c analyzers.
Within Run precision CV%:
5.6% HbA1c: Mean (%) 5.4, SD (%) 0.13, CV% 2.4% (n=40)
7.4% HbA1c: Mean (%) 7.4, SD (%) 0.22, CV% 3.0% (n=40)
11.5% HbA1c: Mean (%) 11.4, SD (%) 0.13, CV% 1.2% (n=40)
Total Precision CV%:
5.6% HbA1c: Mean (%) 5.4, SD (%) 0.15, CV% 2.70% (n=40)
7.4% HbA1c: Mean (%) 7.4, SD (%) 0.19, CV% 2.50% (n=40)
11.5% HbA1c: Mean (%) 11.4, SD (%) 0.15, CV% 1.30% (n=40)
The precision was also evaluated in three physician office laboratories (POL) by trained medical technicians using three different Diazyme HbA1C SMART analyzers. Two unaltered human whole blood HbA1c specimens (approx. 5.5%, 7.5% HbAlc) and one whole blood based control (11.5% HbAlc) were used. Key result: CV
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K0-92911
510(k) Summary
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
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| USA | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4762 | |
| Fax: 858-455-2120 | |
| Date the Summary was Prepared: ' | April 13, 2010 |
| Name of the Device | SMART HbA1c Assay Reagent Kit |
| SMART HbA1c Assay Control Kit | |
| SMART Analyzer | |
| Trade Name: | SMART HbA1c Assay Reagent Kit |
| SMART HbA1c Assay Control Kit | |
| SMART Analyzer | |
| Common/Usual Name | Assay: Test system, Glycated hemoglobin A1c |
| Instrument: Discrete photometric chemistry analyzer | |
| for clinical use | |
| Device Classification Name | Glycosylated Hemoglobin Assay |
| Product code: | LCP, Glycosylated Hemoglobin |
| JJX, Quality Control Material | |
| JJE, Analyzer, Chemistry (Photometric, Discrete) for | |
| Clinical use | |
| Submission Type | 510k |
| Regulation Number | 864.7470, Glycosylated Hemoglobin Assay |
| 862.1660, Quality Control Material | |
| 862.2160, Discrete Photometric Chemistry Analyzer for | |
| Clinical use |
1
| Device Class | I (Controls), II (Assay) |
|---|---|
| Predicate Device: | The SMART HbA1c Assay is substantially equivalent |
| to the currently marketed Diazyme Direct Enzymatic | |
| HbA1c Assay (K070734). | |
| Manufacturing Address | Diazyme Laboratories |
| 12889 Gregg Court | |
| Poway, CA 92121 | |
| USA | |
| Establishment Registration | 2032900 |
Description of the Device:
SMART HbAlc Assay Kit contains reagents intended for use with the SMART HbA1c analyzer for the quantitative determination of stable HbA1c in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. SMART HbA1c assay reagents are similar to the predicate Direct Enzymatic HbA1c assay reagents (K070734). The similarities and differences in composition and format are noted in Table 1 below. The SMART HbA1c test is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion with Bacillus sp protease. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as substrates for specific recombinant fructosyl valine oxidase (FVO) enzyme, produced in E. coli. The recombinant FVO specifically cleaves N-terminal valines and produces hydrogen peroxide. This, in turn, is measured using a horseradish peroxidase (POD) catalyzed reaction and a suitable chromagen. The HbA1c concentration is expressed directly as %HbA1c by use of a lot specific calibration curve that is stored in an RFID card provided with each SMART test kit. The manufacturer of the SMART HbA1c Assay kit is Diazyme Laboratories.
SMART HbA1c Assay Control Kit is intended for use as quality controls for the SMART HbAlc Assay Reagents and is packaged separately. The OC materials were pre market cleared with predicate device (K070734, K050178) and each lot of SMART HbA1c control kits will be tested with the SMART system during value assignment. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If QC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists. The manufacturer of the SMART HbA1c Assay Control kit is Diazyme Laboratories.
SMART HbA1c analyzer 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 cuvettes. The instrument only uses the Diazyme Reagent System (DRS) cuvettes and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS
2
cuvette is supplied prefilled with R1a and the DRS cap is supplied prefilled with R2. The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to prepare hemolysate samples in micro tubes prefilled with Lysis buffer and prepare R1ab mix by transferring R1b from supplied bottle to cuvette. Users are then instructed to transfer hemolysate to cuvette, snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37C and after a predefined period adds the second reagent found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700mm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The SMART analyzers are manufactured for Diazyme Laboratories by Eurolyser Diagnostica, GMBH (Eurolyser Diagnostica GmbH, Bayernstraße 11a, 5020 Salzburg, AUSTRIA; www.eurolyser.com; Fon: +43 662 432100; Fax: +43 662 432100 50). Eurolyser Diagnostica, GMBH establishment registration number is 3006490192. Eurolyser Diagnostica developed and commercialized the SMART analyzers in Europe with their contract manufacturing partner AKATech, GMBH (AKAtech Produktions- und Handels GmbH, Untermühlberg 1, 4890 Frankenmarkt, AUSTRIA;
http://www.akatech.at/en/index.php?option=com_content&task=view&id=31&I.: +43 (7684) 88 04-0; Fax: +43 (7684) 88 04-9). AKATech is ISO13485 and ISO 9001 quality system certified.
The SMART HbA1c Analyzer System thus consists of the following:
-
- SMART HbAlc Assay Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART HbAlc analyzer.
-
- SMART HbA1c Assay Control Kit. Controls are provided for quality control of the SMART Hba1c assay
-
- SMART Analyzer. SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care testing, designed to analyze readings from single use SMART reagent cuvettes.
Indications for Use:
SMART Hemoglobin A1c (Glycated hemoglobin A1c; A1c; HbA1c) reagents are intended for use with the SMART analyzer for the quantitative determination of stable HbA1c in human capillary and venous whole blood samples. Measurement of hemoglobin A 1c is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only.
SMART HbA1c Assay Controls are intended for use as quality controls for the SMART HbA1c Assay reagents. For in vitro diagnostic use only.
SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care use, designed to analyze readings from single use SMART reagent cuvette. The SMART Analyzer System, consisting of the SMART Analyzer, SMART HbA1c reagent kit and SMART HbA1c Assay Controls, is for in vitro diagnostic use only.
3
| Diazyme Direct Enzymatic HbA1c Assay Kit
| (predicate K070734) | SMART HbA1c Assay Kit |
|---|---|
| Kit can be used on automated chemistry analyzers | |
| using validated parameters | Kit can ONLY be used with SMART HbA1c analyzers |
| Lysis buffer | |
| 1 bottle | Lysis buffer |
| 20 micro centrifuge tubes (prefilled) | |
| 100mM CHES 1% Triton X-100 0.45% SDS 0.5mM Redox agents | 100mM CHES 1% Triton X 100 0.45% SDS 0.5mM Redox agents 10µM Redox agents |
| Reagent 1 b | Reagent 1 b |
| 1mM MES 10 U/mL FVO enzyme 90U/mL POD 0.8mM Chromagen | 15 mM Tris pH 8.0 >10 U/mL FVO enzyme 90U/mL POD 0.8mM Chromagen |
| Calibrator set | Calibrator |
| 1 x 0.5mL Calibrator 1 | 1 x preprogrammed lot specific RFID card in each kit |
| 1 x 0.5mL Calibrator 2 | |
| Control Set | Control Set |
| 1 x 0.5mL Control 1 | 1 x 0.5mL Control 1 |
| 1 x 0.5mL Control 2 | 1 x 0.5mL Control 2 |
Table 1 Summary of Assay Kit Components
·
.
.
,
・
4
Performance Testing Summaries:
Precision Study Summary
The precision of the SMART HbA1c Assay was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline with the following modifications: In the study, two unaltered whole blood specimens containing 5.6% and 7.4% HbA1c, one whole blood based HbAlc control containing 11.5% HbA1c were tested with 2 runs per day with duplicates over 10 working days. Reagent Lot 1 was used over the first 5 days and Reagent Lot 2 was used over the remaining 5 days. Both lots of reagents were used on three different SMART HbA1c analyzers. The precision evaluation data are listed below:
The mean value (Mean), standard deviation, within run imprecision and total imprecision CV% are calculated and summarized in the following tables:
| 5.6% HbA1c | 7.4% HbA1c | 11.5% HbA1c | |
|---|---|---|---|
| Total data points | 40 | 40 | 40 |
| Mean (%) | 5.4 | 7.4 | 11.4 |
| SD (%) | 0.13 | 0.22 | 0.13 |
| CV% | 2.4% | 3.0% | 1.2% |
Within Run precision CV%
Total Precision CV%
| 5.6% HbA1c | 7.4% HbA1c | 11.5% HbA1c | |
|---|---|---|---|
| Total data points | 40 | 40 | 40 |
| Mean (%) | 5.4 | 7.4 | 11.4 |
| SD (%) | 0.15 | 0.19 | 0.15 |
| CV% | 2.70% | 2.50% | 1.30% |
The precision of the SMART HbA1c assay was also evaluated in three physician office laboratories (POL) by trained medical technicians to test systemic and random error on three different Diazyme HbA1C SMART analyzers. Two unaltered human whole blood HbA1c specimens containing about 5.5%, 7.5% of HbAlc and one whole blood based control containing 11.5% HbAlc were used. For the three levels of samples tested at the three POL sites, the Diazyme Enzymatic HbA1c SMART assay yielded acceptable precision of CV ≤ 5%.
Between instrument precision and lot-to-lot variation studies were also performed on SMART Hbalc analyzers using a panel of 10 blood samples of blood controls. In both studies, less than 5% of CV was obtained indicating good lot-to-lot consistency and between instrument precision.
5
Comparison Study Summary
Human whole blood samples were tested with the SMART HbA1c Assay and results obtained were compared to the predicate method. A total of 64 samples ranging from 4-12% HbA1c were tested in both assays. The above described accuracy study showed that the SMART HbA1c assay results correlated well with predicate method with a correlation coefficient of 0.96 with a slope of 0.94 and 0.30 intercept.
| Whole blood application | |
|---|---|
| n | 64 |
| Slope | 0.96 |
| Intercept | 0.30 |
| Correlation coeffi | 0.94 |
| Range of values | 4.5% - 11.1% HbA1c |
Interference Study Summary
The following substances normally present in the blood produced less than 10% deviation when tested at levels equal to the concentrations listed below:
| Interference | Concentration |
|---|---|
| Ascorbic Acid | 30 mg/dL |
| Bilirubin | 15 mg/dL |
| Bilirubin Conjugate | 5 mg/dL |
| Uric Acid | 30 mg/dL |
| Triglyceride | 4000 mg/dL |
| Glucose | 5,000 mg/dL |
| Urea | 100 mg/dL |
6
Image /page/6/Picture/0 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 image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Diazyme Laboratories c/o Dr. Abhijit Datta, Director, Technical Operations 12889 Gregg Court Poway, CA 92064
APR 2 6 2010
Re: K092911
Trade Name: SMART HbA1c Assay Reagent Kit, SMART HbA1c Assay Control Kit, SMART Analyzer Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Codes: JJX, JJE Dated: March 18, 2010 Received: March 22, 2010
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (If Known): K092911
Device Name: SMART HbA1c Assay Reagent Kit, SMART HbA1c Assay Control Kit, SMART Analyzer
Indications for Use:
SMART Hemoglobin A1c (Glycated hemoglobin A1c; A1c; HbA1c) Assay Reagent Kit is intended for use with the SMART analyzer for the quantitative determination of stable HbA1c in human capillary and venous whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only.
SMART HbA1c Assay Controls are intended for use as quality controls for the SMART HbA1c Assay reagents. For in vitro diagnostic use only.
SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care use, designed to analyze readings from single use SMART reagent cuvette. The SMART Analyzer System, consisting of the SMART Analyzer, SMART HbA1c reagent kit and SMART HbA1c Assay Controls, is for in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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 Safety
510(k) K092911
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