(392 days)
Not Found
No
The device is a chemistry assay performed on a standard laboratory analyzer, utilizing enzymatic methods to measure hemoglobin concentrations. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on standard analytical validation metrics for a quantitative assay.
No
The device is an in vitro diagnostic (IVD) assay used to measure hemoglobin A1c, which aids in the diagnosis and monitoring of diabetes. It does not exert a therapeutic effect on the patient.
Yes
The intended use explicitly states that "Hemoglobin A1c measurements are used as an aid in the diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus." This directly indicates a diagnostic purpose.
No
The device description clearly states it is a "Reagent Kit," "Calibrator Kit," and "Control Kit," which are physical components used in a laboratory assay. It also mentions the assay is performed on the "ARCHITECT c 8000 System," which is a hardware analyzer. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative in vitro measurement of percent hemoglobin A1c... in whole blood and hemolysate". "In vitro" means outside of the living body, and the measurement is performed on biological samples (blood).
- Device Description: The device description details reagents, calibrators, and controls used to perform the assay on a laboratory system. These components are designed to be used in a laboratory setting to analyze biological samples.
- Performance Studies: The performance studies described are typical for an IVD, evaluating aspects like precision, linearity, interference, and method comparison against a reference method. These studies demonstrate the analytical performance of the device for its intended diagnostic purpose.
- Key Metrics: The key metrics reported (imprecision, bias, correlation) are standard for evaluating the performance of quantitative IVD assays.
- Predicate Devices: The mention of predicate devices with K numbers indicates that this device is being compared to other legally marketed IVDs.
The entire description points to a device designed and intended for use in a clinical laboratory to perform diagnostic testing on patient samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hemoglobin A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin A1c (NGSP) or HbA1c fraction mmol/mol (IFCC) in human whole blood and hemolysate on the ARCHITECT c 8000 System. Hemoglobin A1c measurements are used as an aid in the diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
The Hemoglobin A1c Calibrators are for use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 System.
The Hemoglobin A1c Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the Hemoglobin A1c assay on the ARCHITECT c 8000 System.
Product codes (comma separated list FDA assigned to the subject device)
PDJ, LCP, JIT, JJX
Device Description
The Hemoglobin A1c Reagent Kit contains Reagent 1 (52 mL), Reagent 2 (20 mL), and Diluent (2 x 35 mL), estimated for 300 tests per kit. Reagent 1 contains 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine sodium salt (0.000817%) and Protease (Bacterial) ( 0.05 to
§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.
0
FEB 2 8 2014
510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Applicant Name
Judith Wallach, ADD, Regulatory Affairs Project Manager Abbott Laboratories Diagnostics Division Dept. 9V6. AP8 100 Abbott Park Road Abbott Park, IL 60064 Telephone Number: (847) 937-1132 Fax Number: (847) 937-4836 E-Mail: judith.r.wallach@abbott.com Date Summary prepared: January 31, 2013 Revised February 25, 2014
Grace LeMieux, ADD, Regulatory Affairs Director Phone (847) 935-0409 Fax (847) 937-4836 E-mail grace.lemieux(a)abbott.com
2. Device Name
Hemoglobin Alc Hemoglobin Alc Calibrators Hemoglobin Alc Controls
Reagents
Classification Name: Assay, Glycosylated Hemoglobin Regulation Description: Glycosylated hemoglobin assay Trade Name: Hemoglobin Alc Common Name: HbAıc Governing Regulation: 862.1373 Device Classification: Class II Product Code: PDJ, LCP Panel Classification: Chemistry
1
Calibrators
Classification Name: Calibrator, Secondary Regulation Description: Calibrator Trade Name: Hemoglobin A1c Calibrators (1 and 2) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Product Code: JIT Panel Classification: Clinical Chemistry
Controls
Classification Name: Single (Specified) Analyte Controls (assayed and unassaved) Regulation Description: Quality control material (assayed and unassaved) Trade Name: Hemoglobin A1c Controls (Low and High) Common Name: Control Governing Regulation: 862.1660 Device Classification: Class II Product Code: JJX Panel Classification: Clinical Chemistry
3. Predicate Device
Reagents
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay (K121291)
Calibrators
Roche C.f.a.s. (Calibrator for Automated Systems) HbA1c (K052101)
Controls
Roche PreciControl HbA1c norm and PreciControl HbA1c path (K103099)
4. Description of Device
Reagents
The Hemoglobin A1c Reagent Kit contains:
| Component | Number of Bottles x Volume |
|---|---|
| Reagent 1 (R1) | 1 x 52 mL |
| Reagent 2 (R2) | 1 x 20 mL |
| Diluent (A1cDIL) | 2 x 35 mL |
Estimated tests per kit: 300
Calculation is based on the minimum fill volume per kit.
2
| Reagent | Reactive Ingredients | Concentration |
|---|---|---|
| Reagent 1 | 10-(carboxymethylaminocarbonyl)- | |
| 3,7-bis(dimethylamino) | ||
| phenothiazine sodium salt | 0.000817% | |
| Protease (Bacterial) | E. coli , recombinant) | |
| Diluent | Sodium nitrite | > 0.05 to in vitro measurement of |
| percent hemoglobin A₁c (NGSP) or HbA₁c | ||
| fraction mmol/mol (IFCC) in human whole | ||
| blood and hemolysate on the ARCHITECT c | ||
| 8000 System. | ||
| Hemoglobin A₁e measurements are used as | ||
| an aid in the diagnosis of diabetes mellitus, | ||
| as an aid to identify patients who may be at | ||
| risk for developing diabetes mellitus, and for | ||
| the monitoring of long-term blood glucose | ||
| control in individuals with diabetes mellitus. | This test is to be used as an aid in diagnosis of | |
| diabetes and as an aid in identifying patients who | ||
| may be at risk for developing diabetes. The | ||
| COBAS INTEGRA 800 Tina-quant HbA1cDx | ||
| Gen.2 assay is an in vitro diagnostics reagent | ||
| system intended for quantitative determination | ||
| of mmol/mol hemoglobin A1c (IFCC) and % | ||
| hemoglobin A1c (DCCT/NGSP) in hemolysate | ||
| or whole blood on the Roche COBAS | ||
| INTEGRA 800 clinical chemistry analyzer. | ||
| Platform | ARCHITECT c 8000 System | |
| (clinical chemistry analyzer) | Roche COBAS INTEGRA 800 | |
| (clinical chemistry analyzer) | ||
| Methodology | Enzymatic | Immunoassay |
| Specimen Type | Whole blood and Hemolysate: | |
| Dipotassium EDTA | ||
| Lithium Heparin | ||
| Sodium Heparin | ||
| Sodium Fluoride/Disodium EDTA | ||
| Tripotassium EDTA | Whole blood and Hemolysate: | |
| Li-Heparin | ||
| K2-EDTA | ||
| K3-EDTA | ||
| KF/Na₂-EDTA | ||
| Na-Heparin | ||
| NaF/K-oxalate | ||
| NaF/Na₂-EDTA |
:
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7
| Reagent
| Similarities and Differences | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Characteristics | Submission Device | |||||||||
| Hemoglobin A1c | Predicate Device | |||||||||
| COBAS INTEGRA 800 Tina-quant HbA1cDx | ||||||||||
| Gen.2 (K121291) | ||||||||||
| Expected | ||||||||||
| Values | For monitoring diabetic patients, it is | |||||||||
| recommended that glycemic goals are | ||||||||||
| individualized following current professional | ||||||||||
| society recommendations. The American | ||||||||||
| Diabetes Association (ADA) | ||||||||||
| recommendations are summarized in the | ||||||||||
| following table. | ||||||||||
| HbA1c Value Glycemic Goal 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)
erine Serr
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.