Chemistry analyzer A

Glucose · linearity · Chemistry analyzer A

Glucose (mg/dL) · Linearity

Criteria met

2 of 3 questions judged · Linearity and Reportable range met · Accuracy not evaluated

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

Table 1. Acceptance criteria

Question	Limit	Finding	Result
Linearity	Each level mean within ±3.0 mg/dL or ±4.0% of the fitted value, whichever is greater	5 of 5 levels within	Met
Accuracy	No accuracy limit set	Largest bias: level 5	Not evaluated
Reportable range	Claimed 2–750 mg/dL; a level within ±10% of each end or, at the lower end, from 0 up to the limit; all levels between acceptable	Covered, low: level 1; high: level 5	Met

Figure 1. Level means against assigned concentration. Fitted line overlies y = x.

Figure 2. Deviation of each result from the fitted line.

Study details

Matrix: Serum
Method: Hexokinase
Reagent lot: GLU-R2609
Calibrator lot: GLU-C2609
Data: 15 included
Design: 5 levels × 3 replicates

A Data listing

Source: CHEM-A_LIN-2609_20260915.csv. 15 rows, all included.

Study row	Specimen	Level	Assigned (mg/dL)	Result (mg/dL)	Replicate	Source row
1	LIN-2609 L1	1	2	2	1	2
2	LIN-2609 L1	1	2	3	2	3
3	LIN-2609 L1	1	2	2	3	4
4	LIN-2609 L2	2	189	188	1	5
5	LIN-2609 L2	2	189	190	2	6
6	LIN-2609 L2	2	189	187	3	7
7	LIN-2609 L3	3	376	378	1	8
8	LIN-2609 L3	3	376	374	2	9
9	LIN-2609 L3	3	376	377	3	10
10	LIN-2609 L4	4	563	560	1	11
11	LIN-2609 L4	4	563	566	2	12
12	LIN-2609 L4	4	563	562	3	13
13	LIN-2609 L5	5	750	744	1	14
14	LIN-2609 L5	5	750	752	2	15
15	LIN-2609 L5	5	750	747	3	16

1 Results

1.1 Results by level (mg/dL)

Table 2. Results by level (mg/dL)

Level	Assigned	Mean	Deviation from line	Bias
1	2	2.3	−0.1	+0.3
2	189	188.3	−0.6	−0.7
3	376	376.3	+0.9	+0.3
4	563	562.7	+0.7	−0.3
5	750	747.7	−0.8	−2.3

1.2 Fitted line

Line through the 5 level means, 2–750 mg/dL: slope 0.997 (95% CI 0.993–1.002), intercept +0.472 mg/dL (−1.7 to 2.6), residual SD 0.876 mg/dL, R² > 0.9999.

1.3 Level detail

Table 3. Level detail (mg/dL)

Level	N	SD	Fitted	Fitted 95% CI	Deviation (%)	Recovery (%)
1	3	0.577	2.5	0.3–4.6	−5.4	116.7
2	3	1.53	189.0	187.4–190.5	−0.3	99.6
3	3	2.08	375.5	374.2–376.7	+0.2	100.1
4	3	3.06	562.0	560.4–563.5	+0.1	99.9
5	3	4.04	748.5	746.3–750.6	−0.1	99.7

Fitted = the straight line at the assigned concentration. Deviation % = deviation from line / fitted × 100. Recovery = mean / assigned × 100.

1.4 Reportable range

Table 4. Claimed reportable range and the levels nearest its limits

End	Limit (mg/dL)	Window (mg/dL)	Closest level	Assigned (mg/dL)	Result
Lower	2	1.8–2.2	1	2	Met
Upper	750	675.0–825.0	5	750	Met

Window = limit ± 10% of the limit.

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

Unweighted least-squares line of level means against expected concentration, one point per level. At least 3 different expected concentrations are needed.
Deviation = level mean − fitted response. Relative deviation divides by |fitted response|.
Bias = level mean − expected concentration.
R-squared is for information only. Confidence intervals are 95% Student t.
The tested range runs from the lowest to the highest included expected concentration.
Reportable range: each end needs a level within 10% of the limit, a level from zero up to the lower limit also covers the lower end, and every level between them must meet its criteria.

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. r and R² are shown to 4 decimal places. A value that rounds to 1 is shown as > 0.9999. 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	1
Method	response linearity (method ID LMS-LIN-1.22)
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