Chemistry analyzer A

Glucose · calibration verification · Chemistry analyzer A

Glucose (mg/dL) · Calibration verification

Criteria met

2 of 2 questions judged · Accuracy and Range coverage met

Instrument: Chemistry analyzer A (CA-41027)
Study date: Sep 15, 2026

Table 1. Acceptance criteria

Question	Limit		Finding	Result
Accuracy	Each mean within its bias limit; each replicate within its replicate limit		5 of 5 materials within	Met
Range coverage	Low and high within 10% of 2 and 750 mg/dL (or zero at the low end), with a middle material		Covered	Met

Figure 1. Difference from the assigned value at each level: dots, each replicate; open diamonds, the mean with its 95% CI; dash-dot ticks, allowed bias of the mean; dotted ticks, allowed error of each replicate.

Table 2. Accuracy by material

Level	Assigned (mg/dL)	Mean (mg/dL)	Bias (mg/dL)	Bias limit (mg/dL)	Replicate limit (mg/dL)	Within / total
1	2	2.3	0.3	3.0	6.0	3/3 within
2	189	188.3	−0.7	7.6	15.1	3/3 within
3	376	376.3	0.3	15.0	30.1	3/3 within
4	563	562.7	−0.3	22.5	45.0	3/3 within
5	750	747.7	−2.3	30.0	60.0	3/3 within

Study details

Matrix: Serum
Method: Hexokinase
Reagent lot: GLU-R2609
Calibrator lot: GLU-C2609
Data: 15 included
Design: 5 material levels

A Data listing

Source: CHEM-A_LIN-2609_20260915.csv. 15 rows, all included. Every row: within total-error allowance.

Study row	Material	Level	Result (mg/dL)	Replicate	Source row
1	LIN-2609 L1	1	2	1	2
2	LIN-2609 L1	1	3	2	3
3	LIN-2609 L1	1	2	3	4
4	LIN-2609 L2	2	188	1	5
5	LIN-2609 L2	2	190	2	6
6	LIN-2609 L2	2	187	3	7
7	LIN-2609 L3	3	378	1	8
8	LIN-2609 L3	3	374	2	9
9	LIN-2609 L3	3	377	3	10
10	LIN-2609 L4	4	560	1	11
11	LIN-2609 L4	4	566	2	12
12	LIN-2609 L4	4	562	3	13
13	LIN-2609 L5	5	744	1	14
14	LIN-2609 L5	5	752	2	15
15	LIN-2609 L5	5	747	3	16

1 Results

1.1 Supporting estimates

Table 3. Intervals and error allowances

Level	Mean 95% CI (mg/dL)	Bias (%)	Recovery (%)	SD (mg/dL)
1	0.9–3.8	16.7	116.7	0.577
2	184.5–192.1	−0.4	99.6	1.53
3	371.2–381.5	0.1	100.1	2.08
4	555.1–570.3	−0.1	99.9	3.06
5	737.6–757.7	−0.3	99.7	4.04

1.2 Range coverage · Middle material: 3.

Table 4. Endpoint coverage

Endpoint	Window (mg/dL)	Material	Result
Lower	1.8–2.2	1	Met
Upper	675.0–825.0	5	Met

B Methods

B.1 Additional study details

CAP COM.40300 · 9 December 2025	Unmodified FDA-cleared or approved nonwaived tests. Supporting sections: Decision page; Results; Data listing. Associated laboratory evidence: Written assessment for each test and instrument, including investigation of discordant results.
CAP CHM.13550 · 9 December 2025	Chemistry AMR verification materials covering low, middle and high concentrations. Supporting sections: Range coverage; Data listing. Associated laboratory evidence: Material suitability and preparation instructions.
CAP CHM.13600 · 9 December 2025	Chemistry AMR verification with applicable timing, triggers and exceptions. Supporting sections: Range coverage; Decision page. Associated laboratory evidence: AMR schedule and applicable event records.
CAP COM.40475 · 9 December 2025	Approval of nonwaived test validation or verification before clinical use. Supporting sections: Decision page; Sign-off. Associated laboratory evidence: Director or qualified designee signed written assessment and approval tied to each test and instrument.
CAP GEN.20377 · 9 December 2025	Laboratory record retention. Supporting sections: Evidence archive. Associated laboratory evidence: Keep method validation and verification records for the life of the test plus two years, or longer when applicable retention rules require it.
CAP GEN.20450 · 9 December 2025	Corrections to laboratory records. Supporting sections: Data listing; Audit trail. Associated laboratory evidence: Retained original values and traceable corrections.

B.2 Statistical methods applied

Independent assigned values or target ranges determine accuracy; measured results never assign their own accuracy targets.
Total-error allowance is the larger of the entered concentration allowance and percentage of the assigned value. Systematic and random allowances are their entered shares of total error.
Mean bias and every replicate are compared directly with inclusive laboratory limits. A confidence interval does not relax a typed limit.
Assigned-high dilution uses percent × assigned high / 100. Two assigned anchors use linear interpolation in the entered percentages or level indices.
Target-range midpoints locate materials for coverage only; no mean bias is calculated from a range midpoint.
Range coverage needs a material covering each end, a distinct interior material, and acceptable accuracy at every planned level. A material covers an end inside its endpoint window, limit ± max(concentration allowance, percentage × |limit| / 100), with 10% for a blank allowance; a minimal or zero material from zero up to the lower limit also covers the lower end. Of the covering materials, the one nearest the limit covers that end.
Means and sample SDs summarize within-run replicates. Mean confidence intervals use Student t and n − 1 degrees of freedom.

B.3 Decision rules and display precision

Each acceptance criterion compares the unrounded estimate with its limit. Limits include their end values unless marked exclusive. A criterion with a missing estimate, too little data or a failed fit is inconclusive and does not count as met.
Entered results, claims, targets and acceptance limits are shown as entered. Calculated concentrations, SDs and fitted parameters are shown to 1 decimal place, percentages to 1 decimal place, and slopes to 3 decimal places. Very small or large values use exponent notation at the same precision. An SD or limit that would round to zero keeps two significant digits.

C Audit trail

Data version	3
Criteria version	2
Method	calibration verification (method ID LMS-CAL-1.3)
Criteria evaluation	acceptance criteria evaluation (method ID LMS-CRITERIA-1.1)
Import CHEM-A_LIN-2609_20260915.csv	SHA-256 30af7040d07cc68002d413138d5d2612510f2201ee0f85ab7164e8d77762c87d
Report software	0.1.0 · templates 2a6731123b96