510k HbA1c Analyzer Claims: Premier Hb9210™ vs. Tosoh G8/Biorad Variant II Turbo 2.

0/Biorad D-10

510k Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Application Manufacturer Trinity Biotech Tosoh Biorad Biorad
Number 510k Application Number N/A K071132 K090699 K031043

HbA1c Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Accuracy Correlation Coefficient (r2) 0.994 0.998 0.994 0.995
(Correlation) Predicate Device ultra2 G7 Variant II Turbo Variant II

HbA1c Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Linearity/ Linearity vs. mixed samples
Measurable Measurable Range, %HbA1c 3.8 to 23.1 4.0 to 16.9 3.5 to 19.0 4.98 to 12.95
Range Correlation Coefficient (r2) 0.9958 0.9995 N/A N/A
Linearity vs. Ref. Materials
Material Type IFCC Calibrators Commercial Controls N/A N/A
Quantity 8 4 N/A N/A
Correlation Coefficient (r2) 0.9998 0.9999 N/A N/A

HbA1c Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Limits of 0.4 to 2.1x Standard
Limits of Detection (±3% error) Not Listed Not Listed Not Listed
Detection Dilution

HbA1c Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Analytical Interfering Substance
±5% error on HbA1c result ±5% error on HbA1c result ±% error not listed
Specificity (above concentration level)
Labile HbA1c 1500 mg/dL 1000 mg/dL
Carbamylated HbA1c 65 mg/dL 25 mg/dL
Bilirubin 20 mg/dL
Acetaldehyde 25 mg/dL 25 mg/dL
Acetylsalicylic acid 90 mg/dL 50 mg/dL
Lipids (Triglycerides) 1000 mg/dL 1000 mg/dL 6000 mg/dL
Icterus 20 mg/dL 20 mg/dL
EDTA 1800 mg/dL (11X) 10 mg/dL 11X
Sodium Fluoride 1285 mg/dL (3X)
Heparin 225 USP
Interfering Hemoglobin ±10% error on HbA1c result ±10% error on HbA1c result ±10% error on HbA1c result
Hb AS-trait ≤35% = within error limits ≤30% = within error limits 2 of 11 >10% error
Hb AC-trait ≤35% = within error limits ≤30% = within error limits 2 of 9 >10% error
Hb AD-trait ≤35% = within error limits ≤30% = within error limits 2 of 7 >10% error
Hb AE-trait ≤35% = within error limits Co-elutes with HbA1c 1 of 12 >10% error
Hemoglobin F * ≤20% = within error limits ≤10% = within error limits ≤25%= within error limits

*Premier Hb9210 Hemoglobin F Statement:

Following current literature related to the boronate affinity method used with the Premier Hb9210™, the following limitation will be applied in labeling:
Physicians and laboratory professionals need to be aware of potential interference from elevated HbF levels that could affect HbA1c results, including those from
boronate affinity methods. Studies performed by Rohlfing et al* indicate that in the rare instances when HbF is greater than 20% this increase can result in
clinically significant reductions in A1c results. Primus boronate affinity methods showed a mean bias of 0.98% HbA1c when hemoglobin F levels exceeded 20%.
510k HbA1c Analyzer Claims: Premier Hb9210™ vs. Tosoh G8/Biorad Variant II Turbo 2.0/Biorad D-10

*Rohlfing, CL, Connolly,SM, et al. Five Common Hemoglobin A1c Methods Compared With the IFCC Reference Method. Am J Clin Pathol. 2008;129:811-814.

HbA1c Premier Hb9210™ G8 Variant II D-10

Carryover Turbo 2.0
Carryover ≤ 0.1%HbA1c

20 runs were performed over 5 days of the 10 sample data set

consisting of low, decision point and high %HbA1c samples.

1. The coefficients of variance of each level does not exceed the

acceptable product claim.
2. The standard deviation of the high-low samples should be ≤3x the
standard deviation of the low-low samples.

Cumulative Statistics

Carryover Mean 5.46 8.37 11.23 Not Listed Not Listed Not Listed
SD 0.103 0.152 0.182
% CV 1.89 1.81 1.62

L-L Mean 5.41

L-L StDev 0.089
H-L Mean 5.51
H-L StDev 0.110
Pass? Yes

HbA1c Premier Hb9210™ G8 Variant II D-10

Matrix Turbo 2.0
Effects ≤ 0.1%HbA1c difference at clinically significant levels (6.5-8.0%)
Collection
• Capillary blood (fingerstick), collected into an EDTA-treated glass
Methods
capillary
and • Venous blood collected into an evacuated ETDA-treated blood tube
Anticoagul Matrix Effects Not Listed Not Listed Not Listed
• Venous blood collected into an evacuated Heparin-treated blood
ants tube
• Venous blood collected into an evacuated sodium fluoride-treated
blood tube
• 20 tubes collected, each type

HbA1c Premier Hb9210™ G8 Variant II D-10

Matrix Turbo 2.0
Effects – ≤ 0.1%HbA1c difference at clinically significant levels (6.5-8.0%)
Frozen and Matrix Effects Not Listed Not Listed Not Listed
• Frozen hemolysate vs. non-frozen hemolysate
Non-Frozen
510k HbA1c Analyzer Claims: Premier Hb9210™ vs. Tosoh G8/Biorad Variant II Turbo 2.0/Biorad D-10

Samples • Lysates from frozen whole blood vs. non-frozen hemolysate

• Frozen hemolysate vs. lysates from frozen whole blood
• 20 samples each type, EDTA treated blood

HbA1c Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Precision Type: Between-run precision study
Samples: 3 samples representing
normal, decision point and
abnormal levels of %HbA1c.
Study: Analysis on 20 non-
HbA1c Precision
consecutive days. 2 analyses/run,
2 runs/day
Type: Between-run precision study
Samples: 3 samples representing
normal, decision point and
abnormal levels of %HbA1c.
Study: Analysis on 20 non-
consecutive days. 1 analysis/run, 1
run/day
Type: Between-run precision study
Samples: 2 samples representing
normal and abnormal levels of
%HbA1c.
Study: Analysis on 20 non-
Not Listed
consecutive days. 2 analyses/run,
2 runs/day

HbA1c Premier Hb9210™ G8 Variant II Turbo 2.0 D-10

Precision
Mean %HbA1c 5.76 7.07 10.96 5.07 7.39 13.54 5.6 11.4
Data Table
Estimate of repeatability SD 0.07 0.05 0.09

Repeatability %CV 1.26 0.72 0.85

Estimate of precision SD 0.09 0.09 0.16 0.05 0.03 0.06 0.78 0.39

Precision %CV 1.62 1.28 1.50 0.93 0.42 0.44 1.15 0.91